The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)
Trial Parameters
Brief Summary
Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.
Eligibility Criteria
Inclusion Criteria: * 1\. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9). * Age between 18 and 65 years (both inclusive). * Treatment naïve for bariatric surgery or endoscopic bariatric therapy. * Patients that have been evaluated by the local MDT and have indication to ESG. * Willingness to comply with the substantial behavioral modifications program as required by the procedure. * Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study. * Women of childbearing potential should have negative urine beta human chorionic gonadotropin (hCG) pregnancy test and must agree to use acceptable contraception methods throughout the study duration. * Able to comply with study requirements and understand and sign the Informed Consent Form. Exclusion Criteria: * Previous upper GI surgery (except uncomplicated cholecystectomy or appendecto