Trials / Terminated
TerminatedNCT03794206
Vesair Balloon Confirmatory Trial (VECTOR)
CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Solace Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. All subjects will be prospectively treated after the subject has provided informed consent and determination that all study entry criteria have been met.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vesair Balloon | Treatment with Vesair Balloon for one year |
Timeline
- Start date
- 2019-02-11
- Primary completion
- 2019-08-26
- Completion
- 2022-04-28
- First posted
- 2019-01-04
- Last updated
- 2022-06-13
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03794206. Inclusion in this directory is not an endorsement.