ENLIGHT: Adding fundal mucosal ablation to endoscopic sleeve gastrostomy for obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized controlled trial comparing ESG with and without fundal mucosal ablation in adults with BMI ≥30 kg/m2 who have tried other weight-loss methods. Participants are randomized on the day of the procedure to receive ESG plus FMA or ESG alone. The aim is to determine if modifying the gastric fundus with FMA can enhance weight loss and metabolic outcomes beyond ESG alone. The study uses standard ESG techniques and a minimally invasive fundal ablation to explore potential mechanisms related to hunger regulation. Safety and follow-up assessments will monitor weight, metabolic markers, and procedure-related adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female subjects aged ≥18 years
2. Subjects with a BMI ≥30 kg/m²
3. Subjects have a history of failure of at least one prior weight loss attempt, including but not limited to dietary modification, physical exercise, behavioral modification, pharmacologic therapy (alone or in combination), or other non-surgical weight reduction methods.
4. Willing and able to comply with all study requirements, including but not limited to signing a written informed consent form prior to participation, routine follow-up visit schedule, completing all required laboratory, imaging, and additional assessments, and participating in dietary counseling sessions.
5. Women of childbearing potential (i.e., not postmenopausal and not surgically sterilized) must agree to use adequate and effective contraception methods throughout the study period.
6. Able to travel to visit the study site and have access to the internet to facilitate remote follow-up activities, as applicable.

Exclusion Criteria:

1. Prior gastric or bariatric surgery/procedure that may affect the anatomy or feasibility of the intervention, (e.g; prior Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty).
2. Clinically significant structural abnormality that may increase procedural risk or interfere with endoscopic access
3. Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
4. Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
5. Pregnancy, breastfeeding, or any other condition that, in the opinion of the investigator or treating physician, would make participation unsafe or interfere with study procedures.
6. Other cases deemed by the examining physician as unsuitable for safe treatment.

Where it's running

• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Shailendra Singh, MD, FASGE — West Virginia University
• Study coordinator: Zim Warda Hasan, MBBS, MS
• Email: zh00027@mix.wvu.edu
• Phone: 364-203-1900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.