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Optilume™ BPH Catheter System in Men With Symptomatic BPH

NCT04131907 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-04-09

Study results available
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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

  • Benign Prostatic Hyperplasia

Interventions

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)

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • Urotronic Inc.

    lead INDUSTRY

Principal Investigators

  • Steven A Kaplan, MD · Mount Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2022-08-23
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131907 on ClinicalTrials.gov