Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)

Brief Summary

The goal of this clinical study is to learn whether the GastricOn 6-Month Gastric Balloon helps adults with obesity lose weight, and how safe it is. The GastricOn balloon is a soft, temporary device that is placed in the stomach through the mouth using an endoscope (a thin, flexible tube with a camera), without surgery. Once in place, it is filled with saline (salt water). By taking up space in the stomach, it helps people feel full sooner and eat less. The balloon stays in the stomach for about 6 months and is then removed the same way. The main questions this study aims to answer are: How much of their total body weight do participants lose 26 weeks after the balloon is placed? How often do serious side effects related to the device or the procedure occur? Researchers will also look at changes in body mass index (BMI), excess weight loss, appetite, eating habits and participant satisfaction. About 70 adults aged 18 to 60 years with a BMI between 30 and 40 kg/m² will take part at 3 hospitals in Türkiye. All participants will receive the balloon; there is no comparison group. Participants will: Have screening tests, including a physical exam, blood tests and an endoscopy of the stomach Have the balloon placed under light sedation and stay for observation for 1 to 2 hours before going home Take a stomach acid-reducing medicine (proton pump inhibitor) while the balloon is in place Follow a supervised diet and lifestyle program Attend follow-up visits on Day 7 and at Weeks 4, 12, 24 and 26, where their weight is measured, side effects are checked and questionnaires are completed Have the balloon removed under light sedation at Week 24 Participants will have access to a 24/7 advice line during the study.