ProVIDE II Bridging Study
NCT06236802 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-06-10
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.
Conditions
- BPH With Symptomatic Lower Urinary Tract Symptoms
Interventions
- DEVICE
-
ProVee device
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Sponsors & Collaborators
-
ProVerum Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-06
- Primary Completion
- 2024-09-06
- Completion
- 2029-06-01
- FDA Device
- Yes
Countries
- United States
- Ireland
Study Locations
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