TBD Meeting (5257-22)

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

After a 3-year, pandemic-induced hiatus, the American Gastroenterological Association’s Tech Summit returned to a live meeting in San Francisco. As usual, the highlight of the 2-day event, which is sponsored by the AGA Center for GI Innovation and Technology, was the Shark Tank, where selected companies presented lightning-round overviews of their technology and business plans. A panel of sharks and the audience voted for their favorite.

The contestants presented technologies such as a cell phone app to improve gut health (Agora Health), a polypectomy suite (IzoMed), an implantable weight-loss device (Lean Medical), a device to alleviate gastric obstruction in pancreatic cancer (Myka Labs), a pill designed to map out the gastrointestinal system to aid in diagnosis (Rock West Medical Devices), and an endoscopic ultrasound device (EndoSound). 

Six finalists were selected from 20 submissions, and EndoSound was the winner. According to Raman Muthusamy, MD, medical director of endoscopy at UCLA Health and professor of clinical medicine at the University of California, Los Angeles, and past chair of the AGA Center for GI Innovation and Technology, the quality of presentations and the sophistication of the companies have increased year after year. “This was really the very best,” said Dr. Muthusamy.

Both the judges and the audience chose EndoSound. Endoscopic ultrasound (EUS) focuses on diagnosis and treatment of chest and abdomen disorders, particularly the pancreas. The EndoSound device attaches to an upper endoscope and converts it to a fully therapeutic endoscope that can perform all standard EUS procedures. Moreover, it does not use an elevator, which has been linked to infection risk.

Most clinical facilities lack EUS capability: 97% of ambulatory surgical centers and 80% of hospitals. EUS systems have hardly changed since the late 20th century, and they cost about $450,000. The projected cost of the EndoSound device is closer to $50,000.

“Just like colonoscopies and upper endoscopies, most endoscopic ultrasounds ought to be done in surgical centers. The idea that they can do them efficiently, and at lower cost and greater convenience to their patients and themselves, seems to me the way everything is going, and the way this procedure ought to go as well. The only obstacle to that has been the cost of the equipment. If we can take away that obstacle, then people who are already doing procedures in hospitals where it’s not convenient and not efficient, will be able to do the procedures in surgical centers,” said Stephen Steinberg, MD, founder and President of EndoSound.

“It’s a radical redesign. You’ve cut cost and you’ve cut space. And it’s something that could be put on at a moment’s notice. Rather than referring the patient for [ultrasound], it could allow you to do it on the spot, and perhaps save a second trip for a patient. It allows flexibility in terms of site of service,” said Dr. Muthusamy.

Dr. Muthusamy called it a “godsend” for low-resource institutions in the United States or abroad who have the expertise, but not the equipment, to perform EUS. “There’s no question that more EUS procedures could be done than are currently being done because of issues of availability, and this device takes a significant step to alleviate that.”

The Food and Drug Administration has granted a breakthrough device designation to EndoSound, which allows the company to forgo human clinical trials to support the application. “We’re hoping and expecting to have our application in the beginning of the fourth quarter, and with a little bit of luck to be approved by the end of the year. That’s our goal,” said Dr. Steinberg.

The technology started out as a challenge that Dr. Steinberg set for himself. His career overlapped with some of the earliest innovators of therapeutic endoscopy. “They were the stars. I wasn’t, but I was there,” said Dr. Steinberg. In his practice, Dr. Steinberg was doing procedures that included endoscopic ultrasound.

By the new millennium, EUS had gained a lot of interest, but there was a problem. “It was expensive, and it could only be done in hospitals. I started wondering if we couldn’t get it into a different environment by having a simpler solution,” said Dr. Steinberg.

But success didn’t come quickly. “I started drawing on the back of napkins to see if there wasn’t some solution,” said Dr. Steinberg. It wasn’t until a serendipitous meeting occurred that the concept took shape. Dr. Steinberg’s wife was the CEO and provost of Oregon Health Sciences University, Portland, as well as head of the technology transfer program. Dr. Steinberg’s practice, however, was in Florida so he commuted to Oregon every weekend.

One day, she told him about a presentation by Scott Corbett, MD. “My wife said: ‘Hey, they’re doing ultrasound. Why don’t you come and sit in [on the meeting] because I don’t know anything about it.’ [Dr.] Corbett was working with Sonivate, a point-of-care ultrasound company that was developing an ultrasound that could be placed over the end of the finger, to be used in battlefield triage. I thought, well, if you could put it on a finger, why couldn’t you put it on a scope? So, Scott and I got to talking, and went through a couple of iterations that didn’t work, and then finally came up with one that seemed like it was suitable.”

The device has been tested in five animal models with 20 EUS physicians who concluded that the images were equivalent to legacy devices and that they could be adopted quickly. The company also presented results from a human study that demonstrated noninferiority to the latest EUS system from Pentax.

Dr. Steinberg is an employee and stockholder of Sonivate. Dr. Muthusamy has no relevant financial disclosures. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

*Correction, 5/17/22: An earlier version of this article stated that Geneoscopy was a finalist in the competition. It was not. Also, EndoSound should have been listed as a finalist in this paragraph.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.