Endoscopic Gastric Mucosal Ablation for Obesity

(COMET Trial)

Not currently recruiting at 3 trial locations

Overseen By Christopher McGowan, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Erbe Elektromedizin GmbH

Must not be taking: Insulin, Anticoagulants, Anti-inflammatories, others

Disqualifiers: Diabetes, Autoimmune disease, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new, non-surgical weight loss method called endoscopic Gastric Mucosal Ablation (GMA). The procedure uses a special technique to treat stomach tissue, potentially affecting hormones that influence weight. Researchers aim to determine the safety of this approach and its effectiveness in promoting weight loss over six months. Ideal participants are those who have struggled to lose weight despite dieting and lifestyle changes, have maintained a stable weight for the past three months, and have not undergone prior bariatric surgery. As an unphased trial, this study offers a unique opportunity to contribute to innovative weight loss research.

Will I have to stop taking my current medications?

The trial requires participants to avoid using weight loss medications and certain other drugs that affect the gastrointestinal system. If you are on any of these medications, you may need to stop taking them to participate in the study. It's best to discuss your current medications with the study team to see if any changes are needed.

What prior data suggests that this technique is safe for weight loss?

Research shows that endoscopic Gastric Mucosal Ablation (GMA) is generally well-tolerated. Studies have found that participants lose weight without surgery. This method uses a tool called Hybrid Argon Plasma Coagulation (HAPC), which has undergone safety testing.

In various studies, HAPC led to few serious side effects. For example, a recent study found it safe and effective for treating obesity. Participants did not report major problems, though there is a small risk of stomach narrowing, which occurs less often than with traditional methods.

Overall, these findings suggest that GMA with HAPC is a safe option for weight loss. Participants in past studies generally handled the procedure well, with minimal adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Endoscopic Gastric Mucosal Ablation (GMA) for obesity because it offers a unique approach compared to traditional treatments like lifestyle changes, medications, and bariatric surgery. Unlike these options, GMA involves a targeted technique using Hybrid Argon Plasma Coagulation (HAPC) to directly ablate the gastric mucosa, potentially reducing hunger and promoting weight loss. This method is minimally invasive and could offer a safer, less aggressive alternative to surgery with a quicker recovery time. By precisely targeting the stomach lining, GMA represents an innovative way to aid weight loss, providing hope for individuals who struggle with obesity and may not respond well to existing treatments.

What evidence suggests that this endoscopic technique is effective for obesity?

Research has shown that Endoscopic Gastric Mucosal Ablation (GMA) can lead to significant weight loss. Some studies found that patients lost about 8% of their body weight, averaging roughly 9 kg. Additionally, hunger-related hormones like ghrelin decreased by 48%. Another study reported improvements in weight-related health conditions and a total body weight loss of 6%–15% over a year. In this trial, the treatment employs Hybrid Argon Plasma Coagulation (HAPC), which demonstrated a 14.5% weight loss at six months. These findings suggest that GMA could effectively aid weight loss. ^{2 4 6 7 8}

Who Is on the Research Team?

Dilhana Badurdeen, MBBS

Principal Investigator

Mayo Clinic, Jacksonville, Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree not to take any weight loss drugs or supplements during the study.

Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to screening visit

Able to comply with study requirements and understand and sign the Informed Consent Form

Exclusion Criteria

Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical trial participation

Pregnant or breast-feeding or intending to get pregnant during the study

I haven't changed my diabetes medication or doses in the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

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

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Gastric Mucosal Ablation (GMA)
• Hybrid Argon Plasma Coagulation (HAPC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Gastric mucosal ablation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Erbe Elektromedizin GmbH

Lead Sponsor

Trials

14

Recruited

840+

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+

Published Research Related to This Trial

Obesity is a significant risk factor for various gastrointestinal and hepatic diseases, including nonalcoholic fatty liver disease, gastroesophageal reflux disease, and several types of cancer, highlighting the need for awareness of these complications among healthcare providers.

Gastroenterologists play a crucial role in managing obesity-related diseases due to their expertise in nutrition and endoscopic interventions, making them key players in a multidisciplinary approach to treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Complications of Obesity. Camilleri, M., Malhi, H., Acosta, A.[2022]

Citations

1. giejournal.org giejournal.org/article/S0016-5107(25)00312-8/fulltext

ENDOSCOPIC GASTRIC MUCOSAL ABLATION FOR ... The majority of patients presented with one or more comorbidities associated with obesity. At 2 years of post-EGMA, 4/7 (57.1%) patients achieved complete ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20542401

Early Feasibility of Endoscopic Gastric Mucosal Ablation ... The purpose of this study is to assess the feasibility of ablation of up to 70% of the gastric mucosa using HybridAPC to induce weight loss.

3. news.ddw.org news.ddw.org/news/endoscopic-ablation-shows-promise-in-reducing-hunger-and-promoting-weight-loss/

Endoscopic Ablation Shows Promise in Reducing Hunger and ... Patients lost approximately 8% of their body weight, an average of 9 kg. · Plasma ghrelin levels decreased by 48% from 462 pg/mL to 255 pg/mL.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404422/

Recent advances in bariatric endoscopy for obesity ... Despite their short-term benefits — including 6%–15% total body weight loss (TBWL) and improvements in comorbid conditions at 12 months — weight ...

5. ddw.digitellinc.com ddw.digitellinc.com/p/s/endoscopic-ablation-of-the-gastric-fundus-in-adults-with-obesity-a-first-in-human-study-7415

ENDOSCOPIC ABLATION OF THE GASTRIC FUNDUS IN ... Composite WEL-SF score improved from 47.7 ± 16.0 at baseline to 62.4 ± 8.3 at 6 months (p = 0.001). No serious adverse events occurred.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05486338/endoscopic-gastric-mucosal-ablation-as-a-primary-obesity-therapy

Endoscopic Gastric Mucosal Ablation as a Primary Obesity ... This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05587491

HybridAPC for Gastric Mucosal Ablation in Obese Patients. This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require ...

8. ifso.com ifso.com/pdf/martina-de-siena.pdf

a pilot study to evaluate the efficacy and safety of gastric ... Pilot, interventional, single-center study. • 20 patients → BMI ≥ 30 and ≤ 39.9 kg/m2. • HybridAPC will be applied to the gastric.