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ENLIGHT Trial: ESG With Fundal Mucosal Ablation

A Single-center Randomized Controlled Trial Evaluating Whether Adding Fundal Mucosal Ablation (FMA) to Standard Endoscopic Sleeve Gastroplasty (ESG) Leads to Greater Weight Loss, Improved Obesity-related Comorbidities, and Better Metabolic and Hormonal Outcomes Compared With ESG Alone in Adults With Obesity.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for approximately 52 weeks after the procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding treatment to the stomach lining helps people lose more weight than stomach stitching alone. The added treatment targets an area that makes a hunger hormone, while the stitches make the stomach smaller. It is for adults with obesity who have tried to lose weight without success.

The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone. Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized on the procedure day to either ESG with FMA or standard ESG alone. The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone. Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized 1:1 on the procedure day to either ESG with FMA or standard ESG alone. The primary outcome is the difference between groups in percentage total body weight loss at 12 months. Secondary outcomes include percent excess weight loss, fasting ghrelin levels, blood pressure and antihypertensive medication use, lipid profile, fasting glucose, insulin, HbA1c, insulin resistance, hepatic steatosis and fibrosis measures, quality of life, pain, gastric symptoms, appetite and eating behavior, and the frequency and severity of adverse events.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have a body mass index (BMI) of 30 or higher. BMI is a measure based on height and weight.
  • Have tried at least one weight-loss method without success, such as diet, exercise, medicine, or another method without surgery.
  • Agree to and be able to follow all study steps, including signing a consent form, follow-up visits, tests, scans, and diet counseling.
  • If you are a woman who can become pregnant, agree to use effective birth control throughout the study.
  • Be able to travel to the study site and have internet access for remote follow-up when needed.

Who can't join

  • Past stomach or weight-loss surgery or procedures that could affect how the study treatment is done.
  • A major problem with the shape or structure of your body that could make the procedure risky or block access with the viewing tube.
  • A condition linked to higher bleeding risk, such as a serious blood-clotting problem or a severely weakened immune system.
  • A condition that may affect weight or eating, such as slow movement of food through the stomach or gut, long-term belly pain, an eating disorder, or a current mental health condition.
  • Being pregnant or breastfeeding.
  • Any other condition or reason that the study doctor believes would make treatment unsafe or interfere with study procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

WV