Research Project
3495861
The Silicone Intragastric Balloon (SIB) Project is designed to evaluate the effectiveness of an artificial bezoar to induce weight loss in obese adults. Obesity is a major health concern. Obese Americans have an increased risk of heart disease, diabetes, hypertension and other health problems. Weight loss has positive effects but is often very difficult. Alternatives, such as surgery, involve known complications and side effects. The project involves a medically-supervised randomized crossover clinical trial. Obese adults (120) at least 40% overweight who have failed previous weightless programs will participate as outpatients for 24 weeks at 3-4 centers. Fifty percent will have SIB'S in place for the first 12 weeks; all will have SIB's during the second 12 weeks. Subjects will be evaluated for safety, weight lass and health benefits, and will be followed for one year aft--r SIB removal. The SIB induced significant weight loss in animal and initial clinical studies. The design and manufacture of the SIS utilizes technologically sophisticated methods and materials to create a durable, smooth, compliant and biologically inert structure. The nominal volume of 500cc saline is adjustable in situ. The deflated device is minimal in size and is soft and elastic for easy removal.
