f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PINNACLE Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P220029 / PAS001
Date Original Protocol Accepted 06/30/2023
Date Current Protocol Accepted  
Study Name PINNACLE Study
Device Name Optilume™ BPH Catheter System
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, multicenter, double blind, randomized, sham-controlled study with a non-randomized, Pharmacokinetics (PK) study arm To evaluate the safety and efficacy of Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH).
Study Population Male subject 50-80 years old who has symptomatic BPH
Sample Size 162 subjects (98 Test arm, 49 Control arm, 15 PK arm)
Statistical power of 90%, one-sided 0.025 alpha, common standard deviation of 7, mean improvement in the Control arm of 6 points and mean improvement in the Test arm of 12.5 points, and 10% loss of follow-up rate
Key Study Endpoints Primary Effectiveness Endpoint: Observed improvement in IPSS at 12 months post-treatment in the Test arm at least 25% greater than that of the Control arm at 3 months.
Primary Safety Endpoint: Major Device-Related Serious Complications
Secondary Effectiveness Endpoints:
1) average IPSS improvement in the Test arm from baseline to 12 months must be greater than or equal to 30%
2) Percentage of responders at 3 months
3) Durability – Percentage of responders at 12 months
4) The change or increase in Qmax at 12 months
Follow-up Visits and Length of Follow-up Through 5 years


PINNACLE Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 06/29/2024    
2 year report 06/29/2025    
3 year report 06/29/2026    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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