Trials / Unknown
UnknownNCT03570034
Obalon Balloon System Post-Approval Study
Obalon Balloon System - Post-Approval Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 201 (actual)
- Sponsor
- Obalon Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Detailed description
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obalon Balloon System | Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program |
Timeline
- Start date
- 2018-06-15
- Primary completion
- 2020-09-13
- Completion
- 2021-03-13
- First posted
- 2018-06-26
- Last updated
- 2020-04-30
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03570034. Inclusion in this directory is not an endorsement.