Pittsburgh Surgical Outcomes Research Center
Transforming the conduct of clinical research

A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese

The proposed research’s primary objective is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults. The rationale for this study is to collect additional safety, efficacy, and performance data on a larger cohort of subjects to validate benefit-risk profile to support FDA approval. This study will also allow control subjects to cross over and receive the Balloon, affording greater insights into the safety and efficacy of the device.

Research Faculty

Research Type