CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 162 enrolled
Drug / intervention
Optilume BPH Catheter System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04131907
NCT04131907N/AActive
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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

Urotronic Inc.·interventional·Posted Oct 18, 2019·Updated Apr 9, 2025

In Brief

A clinical study evaluating Optilume BPH Catheter System and Optilume Sham Device for Benign Prostatic Hyperplasia. Active but no longer recruiting, targeting 162 participants across 21 sites in 2 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesCanada, United States
CollaboratorsClinLogix. LLC

Timeline

N/AActive
20202021202220232024202520262027
First PostedOct 18, 2019
Enrollment StartFeb 5, 2020
Primary CompletionAug 23, 2022
Study CompletionMay 1, 2027
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.7 years ago

Interventions

Optilume BPH Catheter Systemdevice

The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.

Optilume Sham Devicedevice

21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)