Trials / Active Not Recruiting
Active Not RecruitingNCT06236802
ProVIDE II Bridging Study
ProVIDE II Bridging Study for the ProVee System for BPH
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- ProVerum Medical · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.
Detailed description
This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ProVee device | ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH. |
Timeline
- Start date
- 2024-03-06
- Primary completion
- 2024-09-06
- Completion
- 2029-06-01
- First posted
- 2024-02-01
- Last updated
- 2025-06-10
Locations
8 sites across 2 countries: United States, Ireland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06236802. Inclusion in this directory is not an endorsement.