NCT07792226

ENLIGHT Trial: ESG With Fundal Mucosal Ablation

StatusRecruiting

PhaseNot applicable

SponsorWest Virginia University

Primary completionAug 2027 (estimated)

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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Oct 9, 2026 Recruitment opened Show 5 more changesShow less
- Interventions modified
- Start date: Sep 2026 to Oct 2026
- Eligibility criteria expanded, about 12 words
- Secondary endpoints: 54 to 65
- Site details revised
Aug 24, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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

Timeframe: Baseline to 1 month

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

Timeframe: Baseline to 3 month

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

Timeframe: Baseline to 6 month

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

Timeframe: Baseline to 9 month

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

Timeframe: Baseline to 12 month

Secondary (65)

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

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

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

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

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

Show 60 moreShow less

Number of Participants With Procedure-Related Adverse Events (1 Month)

Number of Participants With Procedure-Related Adverse Events (3 Month)

Number of Participants With Procedure-Related Adverse Events (6 Month)

Number of Participants With Procedure-Related Adverse Events (9 Month)

Number of Participants With Procedure-Related Adverse Events (12 Month)

Change in Plasma Ghrelin level from baseline to 1 month

Change in Plasma Ghrelin level from baseline to 6 month

Change in Plasma Ghrelin level from baseline to 12 month

Change in Systolic Blood Pressure from Baseline to 1 Month

Change in Diastolic Blood Pressure from Baseline to 1 Month

Change in Systolic Blood Pressure from Baseline to 3 Months

Change in Diastolic Blood Pressure from Baseline to 3 Months

Change in Systolic Blood Pressure from Baseline to 6 Months

Change in Diastolic Blood Pressure from Baseline to 6 Months

Change in Systolic Blood Pressure from Baseline to 9 Months

Change in Diastolic Blood Pressure from Baseline to 9 Months

Change in Systolic Blood Pressure from Baseline to 12 Months

Change in Diastolic Blood Pressure from Baseline to 12 Months

Change in Fasting Plasma Glucose from Baseline to 1 Month

Change in Fasting Plasma Glucose from Baseline to 6 Months

Change in Fasting Plasma Glucose from Baseline to 12 Months

Change in Fasting Serum Insulin Concentration from Baseline to 1 Month

Change in Fasting Serum Insulin Concentration from Baseline to 6 Months

Change in Fasting Serum Insulin Concentration from Baseline to 12 Months

Change in Hemoglobin A1c (HbA1c) from Baseline to 1 Month

Change in Hemoglobin A1c (HbA1c) from Baseline to 6 Months

Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months

Change in Total Cholesterol from Baseline to 1 Month

Change in Total Cholesterol from Baseline to 6 Months

Change in Total Cholesterol from Baseline to 12 Months

Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 1 Month

Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 6 Months

Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 12 Months

Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 1 Month

Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 6 Months

Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 12 Months

Change in Triglycerides from Baseline to 1 Month

Change in Triglycerides from Baseline to 6 Months

Change in Triglycerides from Baseline to 12 Months

Change in Hepatic Steatosis Index (HSI) from Baseline to 1 Month

Change in Hepatic Steatosis Index (HSI) from Baseline to 6 Months

Change in Hepatic Steatosis Index (HSI) from Baseline to 12 Months

Change in Liver Stiffness Measurement from Baseline to 1 Month

Change in Liver Stiffness Measurement from Baseline to 6 Months

Change in Liver Stiffness Measurement from Baseline to 12 Months

Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 1 Month

Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 3 Months

Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 6 Months

Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 12 Months

Change in plasma leptin level from baseline to 1 month

Change in plasma leptin level from baseline to 6 months

Change in plasma leptin level from baseline to 12 months

Change in resistance to overeating from baseline to 1 month

Change in resistance to overeating from baseline to 3 months

Change in resistance to overeating from baseline to 6 months

Change in resistance to overeating from baseline to 12 months

Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 1 month

Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 3 months

Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 6 months

Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 12 months

Arms and interventions

ESG with Fundal Mucosal AblationExperimental

Endoscopic Sleeve Gastroplasty (ESG) AloneActive comparator

Devices: Endoscopic Sleeve Gastroplasty (ESG)

Procedures: Fundal Mucosal Ablation

Sites

1 site in 1 country

West Virginia UniversityMorgantown, West Virginia, United States

About this trial

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.

Trial details

Enrollment: 62 participants (estimated)
Started: Oct 2026
Study completion: Aug 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, single blind, treatment
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2, Liver Diseases, Obesity, Vascular Diseases, Obesity (Body Mass Index >30 kg/m2)
Official title: 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.
First posted: Aug 28, 2026
Registry updated: Oct 19, 2026
Last verified: Oct 2026

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