Randomized Comparison of Three Endoscopic Gastroplasty Techniques for Treating Obesity in Adults

What this Trial Is About

Researchers are evaluating three different Endoscopic Gastroplasty EG techniques for treating obesity in adults with a body mass index BMI between 30 and 44.99 kgm2. This study aims to compare the safety and effectiveness of these minimally invasive procedures, which reduce stomach capacity and alter gastric motility, over an 18-month period. The trial is conducted at a single center and involves a multidisciplinary team to assess patients before and after treatment. Participants will be randomly assigned to one of three EG procedures Endoscopic Sleeve Gastroplasty ESG using the Overstitch suturing device, Primary Obesity Surgery Endolumenal-2 POSE-2 with an overtube-style platform, or Endoluminal Vertical Gastroplasty EVG using a triangulation platform. These procedures are performed under general anesthesia by experienced endoscopists. After the procedure, patients receive tailored diets and follow-up care including psychological support and dietician visits at several time points up to 540 days post-treatment. Throughout the study, patients will undergo regular assessments including anthropometric measurements, blood tests, liver ultrasounds with elastography, transit studies, and barium x-rays to monitor changes in weight, stomach size, and liver health. Researchers will evaluate weight loss outcomes such as total body weight loss and excess weight loss, safety through monitoring adverse events, and quality of life using validated questionnaires. The study includes a comprehensive follow-up schedule to support patient adherence and evaluate long-term effects.

Bariatric Endoscopy for Treatment of Obesity