Optilume Catheter for Enlarged Prostate
(PEAK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is the Optilume BPH Catheter System safe for treating an enlarged prostate?
How is the Optilume BPH Catheter System treatment different from other treatments for enlarged prostate?
The Optilume BPH Catheter System is unique because it combines balloon dilation with a localized delivery of paclitaxel (a drug that helps keep the passage open) to treat enlarged prostate symptoms. This minimally invasive procedure can be done in an office setting without general anesthesia, offering favorable outcomes for both urinary and sexual function.12346
What data supports the effectiveness of the Optilume BPH Catheter System treatment for enlarged prostate?
Who Is on the Research Team?
Steven Kaplan, MD, FACS
Principal Investigator
Professor of Urology
Are You a Good Fit for This Trial?
This trial is for men experiencing symptoms of an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Specific eligibility criteria are not provided, but typically participants should be adults with a diagnosis of BPH who meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Optilume BPH Catheter System treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Semen Sub-Study Follow-up
Participants in the semen sub-study are monitored for changes in sperm concentration
What Are the Treatments Tested in This Trial?
Interventions
- Optilume® BPH Catheter System
Optilume® BPH Catheter System is already approved in United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Urotronic Inc.
Lead Sponsor