Fluid-filled Intragastric Balloon's Filling Volume at 500, 600, or 700 Ml for Treatment of Overweight and Obesity: Which is the Magic Number? A Single Centre Randomized Study

What this Trial Is About

Researchers are evaluating the effectiveness and safety of different filling volumes of fluid-filled intragastric balloons in overweight or obese adults with a body mass index (BMI) between 27 and 60 kg/m2. This randomized, single-center study aims to identify which balloon volume—500 ml, 600 ml, or 700 ml—provides the best outcomes for weight loss and safety during treatment. The trial is conducted by a multidisciplinary team including gastroenterologists, surgeons, nutritionists, psychologists, radiologists, and endocrinologists. Participants will be randomly assigned to one of three groups, each receiving an intragastric balloon filled with either 500 ml, 600 ml, or 700 ml of a saline and methylene blue solution. The balloon is inserted through the mouth using a gastroscope and left in place for six months. This fluid-filled balloon reduces stomach volume to support weight loss. After six months, the balloon will be removed by endoscopy. The study runs from August 2022 to June 2025. During the study, participants will undergo thorough evaluations including psychometric, nutritional, and clinical assessments before the procedure. Researchers will monitor weight loss defined by total and excess weight loss percentages, record any adverse events such as pain or nausea, note early balloon removals, and assess quality of life improvements through specific questionnaires. Safety and effectiveness will be observed through these measures over the six-month treatment period.

Intragastric Balloon for Treatment of Overweight and Obesity: Which is the Best Filling Volume?