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A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty (20) CE-marked ReShape™ Balloons in twenty (20) 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 20 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).
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Casa di Cura Solatrix
ReShape Medical, Inc.
Published on BioPortfolio: 2014-07-24T14:10:45-0400
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