Trials / Completed
CompletedNCT03082118
Vesair Continued Access Trial
Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Solace Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Single arm study of the Vesair Balloon in postmenopausal women.
Detailed description
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vesair Bladder Control System | Intravesical balloon |
Timeline
- Start date
- 2017-03-09
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
- First posted
- 2017-03-17
- Last updated
- 2019-07-05
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03082118. Inclusion in this directory is not an endorsement.