Trials / Completed
CompletedNCT01673698
A Prospective, Randomized Multicenter Study to Evaluate the Safety and Efficacy of the ReShape Duo™ Intragastric Balloon System in Obese Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- ReShape Lifesciences · Industry
- Sex
- All
- Age
- 21 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ReShape Duo balloon | |
| OTHER | Diet counseling | |
| OTHER | Exercise counseling |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2014-04-01
- Completion
- 2014-09-01
- First posted
- 2012-08-28
- Last updated
- 2015-12-07
- Results posted
- 2015-12-07
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01673698. Inclusion in this directory is not an endorsement.