What side effects are associated with this type of intervention?

Common treatments for obesity similar to Endoscopic Gastric Mucosal Ablation (GMA) include endoscopic procedures like Argon Plasma Coagulation (APC) and other minimally invasive techniques. Known side effects of these treatments can include gastrointestinal discomfort, nausea, vomiting, and potential bleeding or perforation at the treatment site. Additionally, there may be risks of infection and fibrosis, as well as hormonal changes due to the ablation of gastric mucosa. Long-term effects and efficacy require further study, but these procedures are generally considered to have fewer complications compared to more invasive surgical options.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity, including pharmacological agents and surgical interventions. Pharmacological treatments include drugs like liraglutide, which is a GLP-1 receptor agonist that helps with weight loss by affecting appetite and metabolism. Surgical options include procedures like vertical sleeve gastrectomy (VSG), which involves removing a portion of the stomach and is thought to impact hormonal functions related to hunger and satiety. While there are no FDA-approved treatments exactly like Endoscopic Gastric Mucosal Ablation (GMA) using Argon Plasma Coagulation (APC) combined with waterjet submucosal injection, the concept of targeting the stomach's mucosal layer to influence hormonal pathways is a novel approach that builds on the understanding of how surgical interventions like VSG achieve weight loss.

What other types of research exist?

Promising alternatives to Endoscopic Gastric Mucosal Ablation (GMA) for obesity treatment include: 1) Intragastric Balloons: These are non-surgical devices placed in the stomach to induce a feeling of fullness, though their long-term efficacy and safety are still under evaluation. 2) Pharmacotherapy: New medications targeting hormonal pathways, such as GLP-1 receptor agonists (e.g., semaglutide), have shown significant weight loss benefits. 3) Endoscopic Sleeve Gastroplasty (ESG): This minimally invasive procedure reduces stomach size using sutures, leading to weight loss by limiting food intake and potentially affecting gut hormones. 4) Bariatric Surgery: Procedures like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) remain highly effective for severe obesity, with established benefits on weight loss and metabolic health.

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Procedure

Endoscopic Gastric Mucosal Ablation for Obesity (COMET Trial)

N/A

Waitlist Available

Led By Dilhana Badurdeen, MBBS

Research Sponsored by Erbe Elektromedizin GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new non-surgical weight loss method called GMA for obese people. It uses a tube with a camera to treat the stomach lining with argon gas and waterjet, which helps reduce hunger hormones.

Who is the study for?

This trial is for adults aged 22-60 with a BMI of 30 to ≤45, who have unsuccessfully tried diet and lifestyle weight loss methods. They must not have had bariatric surgery or therapy before, agree to avoid weight loss drugs during the study, use contraception if applicable, and be able to follow the study's requirements.

What is being tested?

The trial tests a new non-surgical weight loss method called endoscopic Gastric Mucosal Ablation (GMA) using Hybrid Argon Plasma Coagulation (HAPC). Participants will undergo this procedure and their total body weight loss will be tracked over six months.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, abdominal pain, nausea, risks associated with endoscopy such as bleeding or infection, and possible changes in bowel habits or stomach function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total body weight loss

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gastric mucosal ablationExperimental Treatment1 Intervention

Participants receive submucosal injection followed by ablation of gastric mucosa using Hybrid Argon Plasma Coagulation (HAPC)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as Endoscopic Gastric Mucosal Ablation (GMA), work by reducing stomach volume or altering hormonal signals that regulate hunger and satiety. GMA specifically uses Argon Plasma Coagulation (APC) combined with waterjet submucosal injection to ablate the gastric mucosa, potentially affecting hormones like ghrelin that stimulate appetite. By decreasing ghrelin levels, these treatments can help reduce hunger and promote weight loss. Understanding these mechanisms is important for obesity patients as it shows how these treatments target both physical and hormonal aspects of appetite control, aiding in effective weight management.

Use of intragastric balloons for weight reduction. An experimental study.Bariatric Radioembolization: A Pilot Study on Technical Feasibility and Safety in a Porcine Model.The effect of exogenous GLP-1 on food intake is lost in male truncally vagotomized subjects with pyloroplasty.