CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
ReShape Duo Balloondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01024465
NCT01024465N/ACompleted
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ReShape Intragastric Balloon for the Treatment of Obesity

ReShape Lifesciences·interventional·Posted Dec 2, 2009·Updated Sep 29, 2015

In Brief

A clinical study evaluating ReShape Duo Balloon for Obesity. Completed, enrolled 26 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesItaly
CollaboratorsRegional Hospital. Viale Rodolfi 37. 36100 Vicenza. ITALY, Casa di Cura Solatrix. Via Bellini 11. 38068 Rovereto. ITALY

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 years ago

Interventions

ReShape Duo Balloondevice

ReShape Duo Balloon