Evaluating Safety and Weight Loss Effects of Pylorus Sparing Antral Myotomy PSAM Alone for Obesity in Adults

What this Trial Is About

Obesity, characterized by a body mass index BMI over 30 kgm2, is a growing global health concern affecting a significant portion of the adult population. This research investigates a novel endoscopic weight loss procedure called Pylorus Sparing Antral Myotomy PSAM, which aims to delay gastric emptying to promote weight loss. PSAM has previously been combined with endoscopic sleeve gastroplasty ESG, showing promising results, but this study evaluates PSAM alone to understand its safety, tolerability, and short-term effectiveness. PSAM involves an endoscopic procedure performed under general anesthesia where a myotomy is created in the antral region of the stomach while preserving the pylorus. The technique uses submucosal endoscopy principles similar to gastric per-oral endoscopic myotomy G-POEM. Patients receive PSAM with standard lifestyle modification therapy. The study includes three groups based on prior endoscopic bariatric therapy status no prior therapy, prior primary therapy, and prior revision therapy. Participants will have assessments at screening, procedure day, and multiple follow-up points up to 12 months. Evaluations include weight change, adverse events, tolerability, quality of life, gastric emptying, hormone levels, glucose metabolism, and gastric motility. The study continuously monitors safety and physiological changes to provide comprehensive data on the procedures impact, informing the design of larger future trials.

Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure