NCT01061385

The Safety and Efficacy of the ReShape Intragastric Balloon in Obese Subjects

IDE G090121 A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Intragastric Balloon (RIBTM) in Obese Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	ReShape Intragastric Balloon	Placement of ReShape Medical Intragastric Balloon for twenty four weeks
OTHER	Control Arm	Behavioral Modification (Diet and exercise counseling) alone

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2010-02-03
• Last updated: 2016-05-13
• Results posted: 2015-12-07