← Back to Search

Procedure

Endoscopic Gastric Mucosal Ablation for Obesity (COMET Trial)

N/A
Recruiting
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
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
Male or female 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

COMET Trial Summary

This trial is investigating a new, minimally-invasive weight loss technique that doesn't require surgery. The study will assess the safety and feasibility of the treatment and will follow participants for up to 12 months to determine the outcome of the procedure.

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.Check my eligibility
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.See study design
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.

COMET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree not to take any weight loss drugs or supplements during the study.
Select...
My BMI is between 30 and 45, and I may have health issues related to my weight.
Select...
I have never had weight loss surgery or non-surgical weight loss procedures.
Select...
I am between 22 and 60 years old.
Select...
I have tried and failed to lose weight through diet and exercise.

COMET Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total body weight loss

COMET 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)

Find a Location

Who is running the clinical trial?

Erbe Elektromedizin GmbHLead Sponsor
10 Previous Clinical Trials
546 Total Patients Enrolled
4 Trials studying Obesity
102 Patients Enrolled for Obesity
Erbe USA IncorporatedOTHER
9 Previous Clinical Trials
1,086 Total Patients Enrolled
4 Trials studying Obesity
80 Patients Enrolled for Obesity
Dilhana Badurdeen, MBBSPrincipal InvestigatorMayo Clinic, Jacksonville, Florida

Media Library

Endoscopic Gastric Mucosal Ablation (GMA) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05486338 — N/A
Obesity Research Study Groups: Gastric mucosal ablation
Obesity Clinical Trial 2023: Endoscopic Gastric Mucosal Ablation (GMA) Highlights & Side Effects. Trial Name: NCT05486338 — N/A
Endoscopic Gastric Mucosal Ablation (GMA) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05486338 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an open call for participants in this research?

"Based on clinicaltrials.gov, this particular medical trial is not currently recruiting patients. The investigation was initially posted in December of 2022 and last amended in August of the same year. Although no longer recruiting participants now, there are 957 other trials actively searching for volunteers at present."

Answered by AI

Does this research endeavor allow for geriatric participation?

"Patients aged 22 to 60 are eligible for participation in this clinical trial. Conversely, there exist 202 trials available specifically for individuals under 18 years old and 596 endeavours that cater to those over 65."

Answered by AI

What are the prerequisites for participating in this research?

"In order to be accepted into this study, potential volunteers must have a body composition indicative of adiposity and fall between the ages of 22 to 60. The current enrollment quota is 15 participants."

Answered by AI

Who else is applying?

What site did they apply to?
Other
True You Weight Loss
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

Frustrated that I can't loose weight no matter how hard I try and what I have tried.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Mayo Clinic: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
~10 spots leftby Aug 2025