REvision of VSG with Ablation of the Mucosa Procedure
The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.
• Male and female patients who have:
∙ BMI of 30 kg/m2 or greater, AND
‣ regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%
• Must have undergone SG at least three years before the time of enrollment
• Age range: 22 - 60 years
• Must agree to refrain from using weight loss medications such as Meridia, Saxenda, Januvia, Xenical, Duromine, GLP-1 agonists (e.g., Ozempic, Wegovy) and dual GLP-1/GIP agonists (e.g., Mounjaro, Zepbound), as well as any over-the-counter weight loss medications or supplements throughout the study.
• Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
• Must agree not to donate blood during participation in the study.
• Should be able to comply with study requirements, understand, and sign the Informed Consent Form.
• Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to the screening visit.
• Should have a history of failure to lose weight using conventional diet and lifestyle therapies.
⁃ Must have reliable access to wifi and/or internet services.
⁃ Must express willingness to comply with the substantial lifelong dietary restrictions required by the procedure.