NCT01024465

ReShape Intragastric Balloon for the Treatment of Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: ReShape Lifesciences · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	ReShape Duo Balloon	ReShape Duo Balloon

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2011-03-01
• First posted: 2009-12-02
• Last updated: 2015-09-29
• Results posted: 2015-09-11

Locations

2 sites across 1 country: Italy