Trials / Recruiting
RecruitingNCT03767595
ProACT Post-Approval Study
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- Sponsor
- Uromedica · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ProACT Adjustable Continence Therapy for Men | The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected. |
Timeline
- Start date
- 2019-02-19
- Primary completion
- 2025-09-01
- Completion
- 2030-09-01
- First posted
- 2018-12-06
- Last updated
- 2024-11-29
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03767595. Inclusion in this directory is not an endorsement.