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ReShape Intragastric Balloon for the Treatment of Obesity

2014-07-24 14:10:45 | BioPortfolio

Summary

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).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Obesity

Intervention

Intragastric Balloon

Location

Casa di Cura Solatrix
Rovereto
Italy
38068

Status

Recruiting

Source

ReShape Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:45-0400

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An inflatable device implanted in the stomach as an adjunct to therapy of morbid obesity. Specific types include the silicone Garren-Edwards Gastric Bubble (GEGB), approved by the FDA in 1985, and the Ballobes Balloon.

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