Endoscopic Gastric Mucosal Ablation for Obesity

(COMET Trial)

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Endoscopic Gastric Mucosal Ablation (GMA) with Hybrid Argon Plasma Coagulation (HAPC) for obesity?

Research shows that argon plasma coagulation (APC), a component of the treatment, is effective in treating weight regain after gastric bypass surgery by reducing the size of the gastrojejunal anastomosis (a surgical connection between the stomach and small intestine). This suggests that APC can help manage weight in patients who have undergone bariatric surgery. ^{1 2 3 4 5}

Is Endoscopic Gastric Mucosal Ablation safe for humans?

There is no specific safety data available for Endoscopic Gastric Mucosal Ablation (GMA) or Hybrid Argon Plasma Coagulation (HAPC) in the provided research articles. ^{6 7 8 9 10}

How is the treatment Endoscopic Gastric Mucosal Ablation (GMA) with Hybrid Argon Plasma Coagulation (HAPC) unique for obesity?

Endoscopic Gastric Mucosal Ablation (GMA) using Hybrid Argon Plasma Coagulation (HAPC) is unique because it combines a high-pressure submucosal injection with argon plasma coagulation, which helps to safely and effectively target only the stomach's mucosal layer without affecting deeper tissues. This approach is novel for obesity treatment, as it leverages a technique primarily used for other gastrointestinal conditions, offering a potentially safer and more precise alternative to traditional methods. ^{11 12 13 14 15}

Research Team

Dilhana Badurdeen, MBBS

Principal Investigator

Mayo Clinic, Jacksonville, Florida

Eligibility Criteria

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 am treating my diabetes without using SU, biguanides, or SGLT-2 inhibitors.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dose response for argon plasma coagulation in the treatment of weight regain after Roux-en-Y gastric bypass. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Good Clinical Practices on Argon Plasma Coagulation Treatment for Weight Regain Associated with Dilated Gastrojejunostomy Following Roux-en-Y Gastric Bypass: a Brazilian-Modified Delphi Consensus. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of the argon plasma coagulation in patients with weight regain after gastric bypass: a randomized control trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Argon plasma coagulation of gastrojejunal anastomosis for weight regain after gastric bypass. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Applying an Anti-reflux Suture in the One Anastomosis Gastric Bypass to Prevent Biliary Reflux: a Long-Term Observational Study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Intragastric Balloon for Management of Severe Obesity: a Systematic Review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Acid and nonacid gastroesophageal reflux after single anastomosis gastric bypass. An objective assessment using 24-hour multichannel intraluminal impedance-pH metry. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal Complications of Obesity. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

The current state of bariatric endoscopy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Comparing Patient Selection and 30-day Outcomes Between Single Anastomosis Gastric Bypass and Roux-en-Y Gastric Bypass: a Retrospective Cohort Study of 47,384 Patients. [2023]

11. Greece pubmed.ncbi.nlm.nih.gov

Factors contributing to the failure of argon plasma coagulation hemostasis in patients with nonvariceal upper gastrointestinal tract bleeding. [2010]

12. Turkey pubmed.ncbi.nlm.nih.gov

Pathologic Validation of Endoscopic Ablative Therapy for Gastric Epithelial Neoplasia: A Randomized Controlled Trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a new high-power argon plasma coagulation system (hp-APC) in therapeutic gastrointestinal endoscopy. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Hybrid Argon Plasma Coagulation for Treatment of Gastric Intestinal Metaplasia. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Hybrid Argon Plasma Coagulation for Barrett's Esophagus and for Colonic Mucosal Resection-A Systematic Review and Meta-Analysis. [2023]