Vesair Clinical Trial
NCT04026347 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2022-05-13
Summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Conditions
- Stress Urinary Incontinence
Interventions
- DEVICE
-
Vesair Balloon
Indwelling, intravesical balloon
- OTHER
-
Sham balloon placement
Sham balloon placement procedure
Sponsors & Collaborators
-
Solace Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-01
- Primary Completion
- 2022-02-28
- Completion
- 2022-04-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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