Active — Not RecruitingNot Applicable

Optilume™ BPH Catheter System in Men With Symptomatic BPH

United States162 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 range50 Years – 80 Years

SexMALE

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Inclusion criteria

✓. Male subject 50-80 years of age who has symptomatic BPH
✓. International Prostate Symptom Score (IPSS) ≥ 13
✓. Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
✓. 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
✕. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
✕. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
✕. Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
✕. Confirmed or suspected malignancy of prostate or bladder
✕. Active or history of epididymitis within the past 3 months

What they're measuring

Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)

Timeframe: 12 months

Number of Participants With Major Device Related Serious Complications

Timeframe: 12 months

Trial details

NCT IDNCT04131907

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-23

Results submitted2024-06-20

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials