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NCT04131907 · ClinicalTrials.gov registry record · NA

Optilume™ BPH Catheter System in Men With Symptomatic BPH

A NA study of Benign Prostatic Hyperplasia, sponsored by Urotronic.

Active
Registry status
NA
Development phase
162
Enrollment target
20
Study locations

NCT04131907: Active NA study of Benign Prostatic Hyperplasia, sponsored by Urotronic.

NCT04131907 is a NA study of Benign Prostatic Hyperplasia that is active but no longer recruiting, run by Urotronic. The registered enrollment target is 162 participants, below the 546-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04131907, a NA study of Benign Prostatic Hyperplasia, is active but no longer recruiting, sponsored by Urotronic.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
162 participants
Enrollment target
20
Study locations

Study Summary

PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)

Primary Outcome

The primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary strea

Conditions Studied

Benign Prostatic Hyperplasia

Interventions

  • DEVICE Optilume BPH Catheter System
  • DEVICE Optilume Sham Device

Study Locations (20)

Texas

  • Urology Austin, PLLC - Austin
  • North Austin Urology - Austin
  • Rio Grande Urology - El Paso
  • Clear Lake Specialties - Webster

New York

  • AccuMed Research Associates - Garden City
  • Manhattan Medical Research Practice, PLLC - New York
  • Weill Cornell Medical College - New York

Florida

  • Advanced Urology Institute - Daytona Beach
  • Florida Urology Partners - Tampa

Maryland

  • Chesapeake Urology Research Associates - Hanover
  • Chesapeake Urology Research Associates - Towson

Arkansas

  • Arkansas Urology - Little Rock

Colorado

  • Colorado Clinical Research - Golden

Illinois

  • Comprehensive Urologic Care - Lake Barrington

Louisiana

  • Regional Urology, LLC - Shreveport

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2020-02-05
Est. Completion 2027-05
Phase NA
Urotronic

8 total trials

What the registry record for NCT04131907 still lists

NCT04131907 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Optilume BPH Catheter System is the first listed.

NCT04131907 names 20 study sites across 13 states, led by Texas, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT04131907 about?

NCT04131907 is a clinical study titled "Optilume™ BPH Catheter System in Men With Symptomatic BPH". PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)

What is the current status of trial NCT04131907?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 162 participants. The study started on 2020-02-05. Estimated completion is 2027-05.

What conditions does trial NCT04131907 study?

This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.

What interventions are being tested in trial NCT04131907?

The interventions under investigation include: Optilume BPH Catheter System (DEVICE), Optilume Sham Device (DEVICE).

Who is sponsoring clinical trial NCT04131907?

This trial is sponsored by Urotronic, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04131907 being conducted?

This trial has 20 study locations across Arkansas, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Benign Prostatic Hyperplasia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04131907's enrollment target sits among peer trials

162 13th of 29 higher than 17 of 29 other Benign Prostatic Hyperplasia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04131907, the US trial registry maintained by the National Library of Medicine. NCT04131907 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.