The purpose of this study is to evaluate the safety and potential advantages of an investigational device called the Allurion Gastric Balloon System (AGBS), which has been developed for the treatment of adult individuals who are obese. The main component of the AGBS is the Allurion Balloon, which is made up of a thin membrane that takes on an ellipsoid shape in the stomach when it is filled by the filling system. First, the balloon will be empty and rolled up into a small, soft capsule; it is delivered into the stomach by swallowing. The Balloon is designed to reside in the stomach for approximately 16 weeks, after which it breaks down and releases all the fluid. Following emptying, it transits the remainder of the GI tract and is naturally excreted. The Allurion Balloon has been tested in other studies, and the results suggest that it may be useful in reducing weight.
What is the full name of this clinical trial?
A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults with Obesity A Prospective, Open-Lbl, Multi-Ctr, Random, Pivotal Safety & Efficacy Study of Allurion Gastric Balloon Sys + Mod Intensity Lifestyle Modification Therapy vs Mod Intensity Lifestyle Modification Therapy for Treatment of Adults w/Obesity