NCT05486338

Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Early Feasibility [COMET EF] - Step II

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Erbe Elektromedizin GmbH · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Obesity
• Adiposity

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-09-05
• Primary completion: 2025-04-18
• Completion: 2026-03-01
• First posted: 2022-08-03
• Last updated: 2026-01-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study