At a glance
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IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects
In Brief
A clinical study evaluating ReShape Intragastric Balloon and Control Arm for Obesity. Completed, enrolled 30 participants.
Detailed Summary
The study evaluated the safety and efficacy of the ReShape Intragastric Balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. The study device is designed to occupy space within the stomach and induce satiety. After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (with endoscopic placement of study device) or the control group (no placement of study device) on an unblinded basis. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48 week study duration.
Study Details
Timeline
Interventions
Placement of ReShape Medical Intragastric Balloon for twenty four weeks
Behavioral Modification (Diet and exercise counseling) alone