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ReShape Intragastric Balloon for the Treatment of Obesity

NCT01024465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-09-29

Study results available
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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

Interventions

DEVICE

ReShape Duo Balloon

ReShape Duo Balloon

Sponsors & Collaborators

  • Regional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY

    collaborator UNKNOWN

  • Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY

    collaborator UNKNOWN

  • ReShape Lifesciences

    lead INDUSTRY

Principal Investigators

  • Mary Lou Mooney · ReShape Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-05-31
Completion
2011-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024465 on ClinicalTrials.gov