Trials / Unknown
UnknownNCT04095481
Obalon Navigation/Touch System Post-Approval Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,600 (estimated)
- Sponsor
- Obalon Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
Post-approval study for the Obalon Navigation/Touch System (NTS)
Detailed description
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confirm results observed in the supplemental PMA IDE study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Obalon Navigation/Touch System | The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon |
Timeline
- Start date
- 2019-12-03
- Primary completion
- 2023-05-30
- Completion
- 2023-05-30
- First posted
- 2019-09-19
- Last updated
- 2019-12-23
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04095481. Inclusion in this directory is not an endorsement.