Trials / Unknown
UnknownNCT02927665
A Prospective Multicenter Post Approval Study of the ReShape™ Integrated Dual Balloon System in Obese Subjects
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 186 (actual)
- Sponsor
- ReShape Lifesciences · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The ReShape Post Approval Study is a prospective multicenter study of the ReShape(TM) Integrated Dual Balloon System in Obese Subjects.
Detailed description
The ReShape Post Approval Study is a post-approval, multicenter, single arm, open label clinical study intended to collect valid scientific evidence regarding the safety and efficacy of the ReShape Dual Balloon as an adjunct to diet and exercise in the treatment of BMI 30-40 subjects with one or more obesity-related comorbid conditions in a commercial clinical setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Reshape Integrated Dual Balloon |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2019-11-01
- Completion
- 2019-12-01
- First posted
- 2016-10-07
- Last updated
- 2019-03-29
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02927665. Inclusion in this directory is not an endorsement.