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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220029 / PAS002 |
| Date Original Protocol Accepted |
08/25/2023
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| Date Current Protocol Accepted |
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| Study Name |
PEAK PAS
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| Device Name |
Optilume™ BPH Catheter System
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| Clinical Trial Number(s) |
NCT04131907
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, single-arm, multi-center, post market clinical trial to verify the continued safety and effectiveness for the Optilume BPH Catheter System
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| Study Population |
Male subject greater than or equal to 50 years old
Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
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| Sample Size |
Number of subjects: 92, 34 in semen sub-study
Assumptions for sample size estimation:
One-sided alpha of 0.025 and 80% power, based on performance goal of 30% improvement in International Prostate Symptom Score (IPSS) giving a minimum sample size of 73. Accounting for approximately 20% loss to follow-up through the full duration of the study (5 years) gives a total sample size of 92 subjects.
Semen sub-study sample size is based on anticipated standard deviation of 60%, performance goal of not more than 30% decrease from baseline, and statistical power of 80%, based on one-sided 0.025 alpha level t-test for a mean for 34 subjects.
Number of sites: 15
Sites location: within the United States
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| Key Study Endpoints |
Safety Endpoints
Primary: Freedom from composite treatment-related serious adverse events.
Secondary (semen sub-study only): The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).
Ancillary: Frequency and severity of treatment-related adverse events. Change from baseline in semen characteristics over time (semen sub-study only).
Effectiveness Endpoints
Primary: Average International Prostate Symptom Score (IPSS) improvement from baseline to 12 months.
Ancillary:
Improvement in IPSS over time
Improvement in Internation Continence Society (ICS) male short form over time
Improvement in peak urinary flow (Qmax) over time
Improvement in post-void residual volume (PVR) over time
Freedom from repeat intervention (time-to-event)
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| Follow-up Visits and Length of Follow-up |
Follow-up visits at 1-, 3-, 6-, and 12-months post-procedure, and annually thereafter through 5 years
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