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ProVee Urethral Expander System IDE Study (ProVIDE)

NCT05186740 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2026-04-23

Study results available
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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).

Conditions

  • BPH With Symptomatic Lower Urinary Tract Symptoms

Interventions

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.

Sponsors & Collaborators

  • ProVerum Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2024-03-15
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186740 on ClinicalTrials.gov