ENLIGHT Trial: ESG With Fundal Mucosal Ablation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic Sleeve Gastroplasty (ESG)
Procedure/SurgeryEndoscopic 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
Procedure/SurgeryFundal 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: ESG with Fundal Mucosal AblationExperimental treatment 2 interventions
Group B: Endoscopic Sleeve Gastroplasty (ESG) AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month
Time frame
Baseline to 1 month2
Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month
Time frame
Baseline to 3 month3
Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month
Time frame
Baseline to 6 month4
Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month
Time frame
Baseline to 9 monthSecondary outcomes
1
Percent change in Excess Weight Loss (%EWL) from baseline to 1 month
Time frame
Baseline to 1 month2
Percent change in Excess Weight Loss (%EWL) from baseline to 3 month
Time frame
Baseline to 3 month3
Percent change in Excess Weight Loss (%EWL) from baseline to 6 month
Time frame
Baseline to 6 month4
Percent change in Excess Weight Loss (%EWL) from baseline to 9 month
Time frame
Baseline to 9 monthSponsors and contacts
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Source ClinicalTrials.gov
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