Recruiting

ESG & FMA

Sponsor:

West Virginia University

Code:

NCT07792226

Conditions

Obesity

Obesity (Body Mass Index >30 kg/m2)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Sleeve Gastroplasty (ESG)

Fundal Mucosal Ablation

Study Details

Brief summary:

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.

Conditions

Obesity

Obesity (Body Mass Index >30 kg/m2)

Study ID

NCT07792226

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ESG with Fundal Mucosal Ablation

active comparator: Endoscopic Sleeve Gastroplasty (ESG) Alone

Interventions

Endoscopic Sleeve Gastroplasty (ESG)

Endoscopic sleeve gastroplasty (ESG) is performed under general anesthesia using a flexible endoscope and full-thickness endoscopic suturing. Sutures are placed along the greater curvature of the stomach to create a smaller, sleeve-like gastric configuration while preserving the gastric fundus. The procedure is intended to reduce gastric volume, promote earlier satiety, and support weight loss.

Fundal Mucosal Ablation

Fundal mucosal ablation is performed during the same procedural session as endoscopic sleeve gastroplasty. The gastric fundal mucosa is lifted using a submucosal injection of saline and methylene blue and then treated with controlled Hybrid Argon Plasma Coagulation. The procedure is intended to ablate superficial ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and supporting weight loss.

Primary outcome measure

  • Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month [ Time Frame: Baseline to 1 month ]
  • Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month [ Time Frame: Baseline to 3 month ]
  • Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month [ Time Frame: Baseline to 6 month ]
  • Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month [ Time Frame: Baseline to 9 month ]
  • Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month [ Time Frame: Baseline to 12 month ]

Central Contacts and Locations

Central contacts

Zim Warda Hasan, MBBS, MS

364-203-1900zh00027@mix.wvu.edu

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Zim Warda Hasan, MBBS, MS

364-203-1900zh00027@mix.wvu.edu

Principal Investigator:

Shailendra Singh, MD, FASGE

More Information

Sponsor

West Virginia University

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Obesity
  • Diabetes Mellitus
  • MASH
  • Circulation Disorder
  • Diabetes Prevention
  • Type 2 Diabetes (Adult Onset)
  • Vascular Disease
  • Liver Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.