Study of Endoscopic Gastric Tubulization for Adults with Morbid Obesity Using the Overstitch Endoscopic Suture Device

What this Trial Is About

Researchers are collecting data on adult patients with morbid obesity who undergo endoscopic gastric tubulization, a less invasive alternative to bariatric surgery. This observational study aims to evaluate weight loss, improvements in quality of life, and reductions in obesity-related health problems over two years after the procedure. The study also seeks to assess the reproducibility and durability of this technique. The treatment involves using the CE marked Overstitch endoscopic suture device to reduce stomach size by merging tissues without incisions. This gastric restriction method is designed to mimic the effects of traditional surgical procedures but with fewer risks and is reversible, allowing for future surgical or endoscopic interventions if needed. The procedure has been standard practice at the Digestive Surgery Department of the Nouvel Hpital Civil since October 2016. Participants are followed from their last visit before the procedure through two years after treatment. Researchers will monitor changes in weight, excess weight loss, and body mass index at multiple time points up to 24 months. Additional assessments include procedure-related adverse events, improvements in comorbidities, quality of life, gastrointestinal health, satiety, and evaluations of the upper gastrointestinal tract through radiologic and endoscopic exams. The study also records procedure duration and the number of stitches used.

Endoscopic Gastric Tubulization