Optilume™ BPH Catheter System for Enlarged Prostate
(PINNACLE Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen bySteven A Kaplan, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Urotronic Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a special catheter designed to treat men with an enlarged prostate. The device helps to open up the urinary passage, making it easier to urinate. The goal is to see if this treatment is safe and effective for these patients.

Eligibility Criteria

Men aged 50-80 with symptomatic BPH, having a prostate size of 20 to 80 gm and specific urinary flow rates. They must have had an inadequate response or contraindication to BPH medical therapy. Exclusions include those with certain prostate conditions, recent use of specific drugs, history of hypersensitivity reactions to paclitaxel, confirmed malignancies, uncontrolled diabetes, and more.

Inclusion Criteria

International Prostate Symptom Score (IPSS) ≥ 13

My prostate size is between 20 to 80 grams as measured by ultrasound.

Able to complete the study protocol in the opinion of the investigator

+4 more

Exclusion Criteria

I do not have any major health issues that could affect the study.

I have not used 5-alpha reductase inhibitors like Avodart in the last 6 months.

I have had blood in my urine twice in the last 3 months without a clear reason.

+39 more

Participant Groups

The PINNACLE trial is testing the Optilume™ BPH Catheter System against a sham device in men with benign prostatic hyperplasia (BPH). It's designed to see if this system is safe and effective for treating symptoms associated with an enlarged prostate.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pharmacokinetics Optilume ArmExperimental Treatment1 Intervention

A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System

Group II: Optilume™ BPH Catheter SystemExperimental Treatment1 Intervention

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.

Group III: Sham DevicePlacebo Group1 Intervention

The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.