NCT05186740

ProVee Urethral Expander System IDE Study (ProVIDE)

The ProVee Urethral Expander System Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: ProVerum Medical · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH).

Detailed description

This is a prospective, multi-center, randomized, single-blind, sham-controlled study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH). Subjects are assigned to their treatment arm using an unbalanced (2 ProVee:1 Sham) randomization stratified by Investigational Sites.

Conditions

• Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	ProVee Urethral Expander System	ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
PROCEDURE	Urethral Access Sheath	The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.

Timeline

• Start date: 2022-06-09
• Primary completion: 2024-03-15
• Completion: 2028-12-01
• First posted: 2022-01-11
• Last updated: 2025-12-01
• Results posted: 2025-12-01

Locations

17 sites across 3 countries: United States, Canada, Ireland

Regulatory

• FDA-regulated device study