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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 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.

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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)

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

Sponsor

Urotronic

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04131907

The ClinicalTrials.gov registry entry for NCT04131907 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (70% lower). The listed sponsor is Urotronic, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.