ENLIGHT Trial: ESG With Fundal Mucosal Ablation

NCT07792226 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY00000243
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month

  Baseline to 1 month

• Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month

  Baseline to 3 month

• Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month

  Baseline to 6 month

• Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month

  Baseline to 9 month

• Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month

  Baseline to 12 month

Secondary Outcomes (54)

• Percent change in Excess Weight Loss (%EWL) from baseline to 1 month

  Baseline to 1 month

• Percent change in Excess Weight Loss (%EWL) from baseline to 3 month

  Baseline to 3 month

• Percent change in Excess Weight Loss (%EWL) from baseline to 6 month

  Baseline to 6 month

• Percent change in Excess Weight Loss (%EWL) from baseline to 9 month

  Baseline to 9 month

• Percent change in Excess Weight Loss (%EWL) from baseline to 12 month

  Baseline to 12 month

Study Arms (2)

ESG with Fundal Mucosal Ablation

EXPERIMENTAL

Procedure: Endoscopic Sleeve Gastroplasty (ESG); Procedure: Fundal Mucosal Ablation

Endoscopic Sleeve Gastroplasty (ESG) Alone

ACTIVE COMPARATOR

Procedure: Endoscopic Sleeve Gastroplasty (ESG)

Interventions

Endoscopic Sleeve Gastroplasty (ESG) PROCEDURE

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.

ESG with Fundal Mucosal Ablation; Endoscopic Sleeve Gastroplasty (ESG) Alone

Fundal Mucosal Ablation PROCEDURE

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.

ESG with Fundal Mucosal Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥18 years
• Subjects with a BMI ≥30 kg/m²
• 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.
• 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.
• 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.
• Able to travel to visit the study site and have access to the internet to facilitate remote follow-up activities, as applicable.

You may not qualify if:

• 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).
• Clinically significant structural abnormality that may increase procedural risk or interfere with endoscopic access
• Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
• Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
• 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.
• Other cases deemed by the examining physician as unsuitable for safe treatment.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Vascular Diseases; Liver Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Digestive System Diseases

Study Officials

• Shailendra Singh, MD, FASGE

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zim Warda Hasan

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director of Advanced Therapeutic Endoscopy, Director of Bariatric Endoscopy

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)