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Active, not recruiting Not applicable Interventional Results available

Optilume™ BPH Catheter System in Men With Symptomatic BPH

ClinicalTrials.gov ID: NCT04131907

Public ClinicalTrials.gov record NCT04131907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 11:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH

Study identification

NCT ID
NCT04131907
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Urotronic Inc.
Industry
Enrollment
162 participants

Conditions and interventions

Interventions

  • Optilume BPH Catheter System Device
  • Optilume Sham Device Device

Device

Eligibility (public fields only)

Age range
50 Years to 80 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 4, 2020
Primary completion
Aug 22, 2022
Completion
Apr 30, 2027
Last update posted
Apr 8, 2025

2020 – 2027

United States locations

U.S. sites
19
U.S. states
12
U.S. cities
17
Facility City State ZIP Site status
Arkansas Urology Little Rock Arkansas 72211
Colorado Clinical Research Golden Colorado 80401
Advanced Urology Institute Daytona Beach Florida 32114
Florida Urology Partners Tampa Florida 33615
Comprehensive Urologic Care Lake Barrington Illinois 60010
Regional Urology, LLC Shreveport Louisiana 71106
Chesapeake Urology Research Associates Hanover Maryland 21076
Chesapeake Urology Research Associates Towson Maryland 21204
Sheldon Freedman MD, Ltd Las Vegas Nevada 89144
New Jersey Urology Englewood New Jersey 07631
AccuMed Research Associates Garden City New York 11530
Manhattan Medical Research Practice, PLLC New York New York 10016
Weill Cornell Medical College New York New York 10065
Associated Urologists of NC Raleigh North Carolina 27612
Carolina Urologic Research Center Myrtle Beach South Carolina 29572
Urology Austin, PLLC Austin Texas 78745
North Austin Urology Austin Texas 78750
Rio Grande Urology El Paso Texas 79912
Clear Lake Specialties Webster Texas 77598

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04131907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 8, 2025 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04131907 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →