ObesityCOMETNCT05486338
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
A study testing Hybrid Argon Plasma Coagulation (HAPC) in people with Obesity and Adiposity, run by Erbe Elektromedizin GmbH at 2 sites in United States.
Trial summary
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- What is being tested?
- Hybrid Argon Plasma Coagulation (HAPC)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2023to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or females patients in the range of class I to class III obesity (BMI ≥ 30 to ≤ 40 with obesity-related comorbidity or BMI > 40 to BMI ≤ 45).
- Age 22 - 60 yrs.
- Treatment naïve for bariatric surgery or endoscopic bariatric therapy
- Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine or over the counter weight loss medications or supplements throughout the study.
- Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
- Agree not to donate blood during their participation in the study.
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- Able to comply with study requirements and understand and sign the Informed Consent Form.
- Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to screening visit.
- History of failure to lose weight using conventional diet and lifestyle therapies.
Who cannot join
- Patients requiring exogenous insulin.
- HbA1c > 8.5 %
- Pregnant or breast-feeding or intending to get pregnant during the study.
- Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- Probable insulin production failure, defined as fasting C-Peptide serum < 1 ng/mL (333 pmol/l).
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- Previous use of any types of insulin for > 1 month (at any time, except for treatment of gestational diabetes).
- Change in diabetic treatment within the last three months.
- Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors.
- Change of diabetes medication or doses 12 weeks prior to screening visit.
- Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year).
- Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
- Previous upper GI surgery, or other endoscopic bariatric procedures or conditions, prior intra-gastric balloon or another gastric implant.
- History of diabetic gastroparesis.
- Known active hepatitis or active liver disease.
- Acute gastrointestinal illness in the previous 7 days.
- Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
- Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus.
- Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
- Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (>3 cm), cancer or any other disorder of the stomach.
- Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety.
- Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting.
- Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
- History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia.
- Current use of anticoagulation therapy
- Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks post procedure
- Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
- Use of drugs known to affect GI motility (e.g. Metoclopramide).
- Receiving any weight loss medications such as Meridia, Xenical, Saxenda, Januvia, Duromine or over the counter weight loss medications at screening.
- Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening.
- Persistent Anemia, defined as Hemoglobin <10 g/dL.
- Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months.
- Known moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).
- Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
- Active systemic infection.
- Known active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma).
- Subjects with an established diagnosis of Multiple Endocrine Neoplasia syndrome type 1.
- Not a candidate for surgery or general anesthesia.
- Active illicit substance abuse or alcoholism.
- Current smoker or smoking history in the last six months.
- Participating in another ongoing clinical trial of an investigational drug or device.
- Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical trial participation.
- Other medical condition that does not allow for endoscopic procedure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
True You Weight Loss
Cary, North Carolina, 27513
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Early Feasibility [COMET EF] - Step II
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure.
Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC.
Read more
As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment.
After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed.
After the treatments the participants will be followed for up to 12 months to assess the outcome of the GMA procedure.
- Being tested
- Hybrid Argon Plasma Coagulation (HAPC)
- Keywords
- Hybrid Argon Plasma Coagulation, Endoscopic bariatric therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Argon Plasma Coagulation (HAPC)Device
Gastric mucosal ablation is an endoscopic procedure which uses argonplasma coagulation in combination with submucosal injection to achieve selective ablation to the gastric mucosa and preventing thermal damage to the muscle layer.
| Study group | Role | What they receive |
|---|---|---|
| Gastric mucosal ablation | Other | Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid Argon Plasma Coagulation (HAPC) Receives: Device: Hybrid Argon Plasma Coagulation (HAPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight loss
Primary endpoint will be determined as the % of total body weight loss (TBWL). Total body weight loss (TBWL) will be determined as body weight difference at the final 6 months follow up (FU) visit after the last treatment visit in comparison to the body weight prior to the first treatment.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start5 Sep 2023
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erbe Elektromedizin GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Sponsor
- Investigators
- Dilhana Badurdeen, MBBS, Principal investigator, Mayo Clinic, Jacksonville, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486338
- Sponsor's protocol ID
- GMA_2022_01
- Acronym
- COMET
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Oberbach A, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Lehmann S, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization reduces adiposity and improves lipid and glucose metabolism in obese rats. Gastrointest Endosc. 2018 Jan;87(1):288-299.e6. doi: 10.1016/j.gie.2017.04.038. Epub 2017 May 4.
PubMed 28479494Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.
PubMed 29476845Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
PubMed 31788546Oberbach A, Schlichting N, Kullnick Y, Heinrich M, Lehmann S, Retschlag U, Friedrich M, Fayad L, Dietrich A, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization improves blood pressure, renin and cardiovascular lipid deposition in a rat model of obesity. Endosc Int Open. 2019 Dec;7(12):E1605-E1615. doi: 10.1055/a-0990-9683. Epub 2019 Nov 25.
PubMed 31788541Itani MI, Oberbach A, Salimian KJ, Enderle M, Hahn H, Abbarh S, Kendrick K, Schlichting N, Anders RA, Besharati S, Farha J, Fayad L, Kalloo AN, Badurdeen D, Kumbhari V. Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach. Obes Surg. 2022 Feb;32(2):381-390. doi: 10.1007/s11695-021-05773-4. Epub 2021 Nov 19.
PubMed 34797503Maselli DB, Donnangelo LL, Wooley C, Chapman C, Kumbhari V, Mcgowan CE. Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.e3. doi: 10.1053/j.gastro.2024.08.008. Epub 2024 Aug 21. No abstract available.
PubMed 39154777Dolgin E. How to keep weight off after obesity drugs. Nature. 2025 Jun;642(8067):286-288. doi: 10.1038/d41586-025-01770-0. No abstract available.
PubMed 40500323
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Early Feasibility [COMET EF] - Step II
- ClinicalTrials.gov ID
- NCT05486338
- Acronym / sponsor ID
- COMET / GMA_2022_01
- Keywords
- Hybrid Argon Plasma Coagulation, Endoscopic bariatric therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Erbe Elektromedizin GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Erbe USA Incorporated
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure.
Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC.
As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment.
After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed.
After the treatments the participants will be followed for up to 12 months to assess the outcome of the GMA procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric mucosal ablation | Other | Device: Hybrid Argon Plasma Coagulation (HAPC)Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid Argon Plasma Coagulation (HAPC) |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or females patients in the range of class I to class III obesity (BMI ≥ 30 to ≤ 40 with obesity-related comorbidity or BMI > 40 to BMI ≤ 45).
- Age 22 - 60 yrs.
- Treatment naïve for bariatric surgery or endoscopic bariatric therapy
- Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine or over the counter weight loss medications or supplements throughout the study.
- Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
Key exclusion criteria (43 listed)
- Patients requiring exogenous insulin.
- HbA1c > 8.5 %
- Pregnant or breast-feeding or intending to get pregnant during the study.
- Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Argon Plasma Coagulation (HAPC)Gastric mucosal ablation is an endoscopic procedure which uses argonplasma coagulation in combination with submucosal injection to achieve selective ablation to the gastric mucosa and preventing thermal damage to the muscle layer. | Device | Gastric mucosal ablation |
Primary outcome
Total body weight loss
Time frame: 9 months
Primary endpoint will be determined as the % of total body weight loss (TBWL). Total body weight loss (TBWL) will be determined as body weight difference at the final 6 months follow up (FU) visit after the last treatment visit in comparison to the body weight prior to the first treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 28479494Oberbach A, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Lehmann S, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization reduces adiposity and improves lipid and glucose metabolism in obese rats. Gastrointest Endosc. 2018 Jan;87(1):288-299.e6. doi: 10.1016/j.gie.2017.04.038. Epub 2017 May 4.
- Background: PubMed 29476845Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.
- Background: PubMed 31788546Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
- Background: PubMed 31788541Oberbach A, Schlichting N, Kullnick Y, Heinrich M, Lehmann S, Retschlag U, Friedrich M, Fayad L, Dietrich A, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization improves blood pressure, renin and cardiovascular lipid deposition in a rat model of obesity. Endosc Int Open. 2019 Dec;7(12):E1605-E1615. doi: 10.1055/a-0990-9683. Epub 2019 Nov 25.
- Background: PubMed 34797503Itani MI, Oberbach A, Salimian KJ, Enderle M, Hahn H, Abbarh S, Kendrick K, Schlichting N, Anders RA, Besharati S, Farha J, Fayad L, Kalloo AN, Badurdeen D, Kumbhari V. Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach. Obes Surg. 2022 Feb;32(2):381-390. doi: 10.1007/s11695-021-05773-4. Epub 2021 Nov 19.
- Background: PubMed 39154777Maselli DB, Donnangelo LL, Wooley C, Chapman C, Kumbhari V, Mcgowan CE. Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.e3. doi: 10.1053/j.gastro.2024.08.008. Epub 2024 Aug 21. No abstract available.
- Background: PubMed 40500323Dolgin E. How to keep weight off after obesity drugs. Nature. 2025 Jun;642(8067):286-288. doi: 10.1038/d41586-025-01770-0. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilhana Badurdeen, MBBS principal investigator
Mayo Clinic, Jacksonville, Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Argon Plasma Coagulation (HAPC) in people with Obesity and Adiposity, run by Erbe Elektromedizin GmbH at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body weight loss (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486338, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.