NCT04131907

Optilume™ BPH Catheter System in Men With Symptomatic BPH

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Urotronic Inc. · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a prospective, multi-center, double blind, randomized controlled clinical trial in a 2:1 allocation of Test versus sham Control. In addition, a single arm of 15 non-randomized subjects will be added to study the Pharmacokinetics of the drug. The objectives of the study are to assess the efficacy of Optilume BPH Catheter System to alleviate LUTS believed to be secondary to BPH (LUTS/BPH) and to evaluate the safety of Optilume BPH Catheter System in the treatment of LUTS/BPH.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Optilume BPH Catheter System	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.
DEVICE	Optilume Sham Device	21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)

Timeline

• Start date: 2020-02-05
• Primary completion: 2022-08-23
• Completion: 2027-05-01
• First posted: 2019-10-18
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

21 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study