Optilume™ BPH Catheter System in Men With Symptomatic BPH (NCT04131907) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optilume™ BPH Catheter System in Men With Symptomatic BPH
United States, Canada162 participantsStarted 2020-02-05
Plain-language 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)
Who can participate
Age range
50 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male subject 50-80 years of age who has symptomatic BPH
. International Prostate Symptom Score (IPSS) ≥ 13
. Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
. Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
. History of inadequate response, contraindication, or refusal of BPH medical therapy
. Able to complete the study protocol in the opinion of the investigator
Exclusion criteria
. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
. Unwilling to abstain or use protected sex for the first 30 days post treatment
. Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
Timeframe: 12 months
2
Number of Participants With Major Device Related Serious Complications