Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity

NCT05574777 | Active Not Recruiting

• 1 other identifier: HAPC GMA
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to investigate safety and feasibility of a new weight loss technique called 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 Class III participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary endpoint device or procedure related occurrence of complications according to Clavien-Dindo classification will be determined. 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 6 months to assess the outcome of the GMA procedure.

Conditions

Morbid; Obesity; Adiposity

Keywords

Endoscopic bariatric therapy; Hybrid Argonplasma Coagulation

Outcome Measures

Primary Outcomes (1)

• Rate of complications related to the device or procedure

  Device or procedure related occurrence of Grade III - V complications according to the Clavien-Dindo classification are defined as follows: * Grade III: complication requiring surgical, endoscopic or radiological intervention * Grade IV: life-threatening complication requiring intermediate care/ intensive care unit management * Grade V: death of a patient

  9 months

Study Arms (1)

Gastric mucosal ablation

OTHER

Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid argonplasma coagulation (HAPC).

Device: Hybrid Argonplasma coagulation (HAPC)

Interventions

Hybrid Argonplasma 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.

Gastric mucosal ablation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients with class III obesity (BMI = 40 and BMI \> 40)
• Age 21 - 75 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, 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.
• 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.

You may not qualify if:

• \) 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 patient diary, 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).
• 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, sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors and metformin (previously used for at least 3 months.
• 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.

Sponsors & Collaborators

• Erbe Elektromedizin GmbH: lead
• Erbe do Brasil Chirúrgicos e Endoscópicos LTDA: collaborator
• Bioscience Consulting, Inc.: collaborator

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Location

Related Publications (7)

• 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.

  PMID: 28479494 BACKGROUND

• Kumbhari 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.

  PMID: 29476845 BACKGROUND

• Fayad 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.

  PMID: 31788546 BACKGROUND

• Oberbach 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.

  PMID: 31788541 BACKGROUND

• Itani 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.

  PMID: 34797503 BACKGROUND

• Maselli 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.

  PMID: 39154777 BACKGROUND

• Dolgin 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.

  PMID: 40500323 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduardo Guimarães H. de Moura, Prof. Dr.

  Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Brasil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: April 13, 2023
• Primary Completion: August 22, 2025
• Study Completion: March 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

BR (1)