Clinical Trial

Optilume™ BPH Catheter System in Men With Symptomatic BPH

Study acronym: PINNACLE
Active, Not Recruiting
View on ClinicalTrials.gov →
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)
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2019-10-16; most recent amendment 2025-04-07.
Status change: Recruiting → Active, Not Recruiting 2022-05-16
Status change: Not Yet Recruiting → Recruiting 2020-03-23
Trial Details
NCT Number NCT04131907
Lead Sponsor Urotronic Inc.
Conditions Benign Prostatic Hyperplasia
Enrollment 162 participants
Start Date 2020-02-05
Primary Completion 2022-08-23 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-30