At a glance
ClinicalIndex Comparison RecordN/ACompleted· 326 enrolled
Drug / intervention
ReShape Duo balloon +2 moredevice
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.
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
In Brief
A clinical study evaluating ReShape Duo balloon, Diet counseling, and 1 other intervention for Obesity. Completed, enrolled 326 participants across 8 sites.
Detailed Summary
The REDUCE Pivotal Trial is a pivotal clinical study designed to develop valid scientific evidence regarding the safety and effectiveness of the ReShape Duo® as an adjunct to diet and exercise in the treatment of obese subjects with one or more obesity-related comorbid conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionApr 2014
Study CompletionSep 2014
TodayJul 2026
First PostedAug 28, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.8 years ago
Interventions
ReShape Duo balloondevice
Diet counselingother
Exercise counselingother