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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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URINATE PAS (PR1276)


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General
Study Status Ongoing
Application Number /
Requirement Number
P210020 / PAS002
Date Original Protocol Accepted 02/03/2022
Date Current Protocol Accepted 06/10/2022
Study Name URINATE PAS (PR1276)
Device Name Optilume Urethral Drug Coated Balloon
Clinical Trial Number(s) NCT03014726 NCT03270384 NCT03499964 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The “Post-market Registry Evaluating the Safety and Effectiveness of the Optilume® DCB in a Real-World Setting” study (PR1276-001 Rev A) is a prospective, single arm, multi-center, non-interventional post market registry evaluating the Optilume DCB in a real-world setting.
The objective of this study is to verify the continued safety and effectiveness for the Optilume® Urethral Drug-Coated Balloon (DCB) in real-world clinical use.
The study duration is anticipated to be up to 7 years from first enrollment. including 2 years for subject recruitment and 5 years for clinical follow-up.
Study Population The study will enroll up to 150 patients at up to 15 sites in the European Union and will be open to male subjects 18 years of age or older who meet the selection criteria, as shown below.
Inclusion Criteria
1. Male subjects greater than or equal to 18 years old.
2. Subject diagnosed with a recurrent stricture in the anterior urethra that is able to be treated with Optilume DCB in accordance with the approved Instructions for Use.
3. Subject is willing to provide informed consent and comply with standard follow-up assessments.
Exclusion Criteria
1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds.
2. Subject is unwilling to abstain or use a condom for 30 days after the procedure.
3. Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential.
Subjects with a history of carcinoma of the genitourinary system (kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.
Sample Size Number of subjects: up to 150 subjects
Sample size was estimated based on a performance goal of 60% and an expected responder rate of 73% at 12 months for the Optilume Urethral DCB. Calculation based on one-sided alpha of 0.025 and 90% power, which results in a minimum required sample size of 139. Accounting for approximately 10% loss to follow-up at 12 months gives a total sample size of 150 subjects. A total of up to 15 sites was chosen to allow for an average of approximately 10 subjects per site, which will allow for an appropriate sample size to conduct site poolability assessments.
Key Study Endpoints Efficacy Endpoints
Primary Efficacy Endpoint
The responder rate, defined as the proportion of subjects experiencing a greater than or equal to 30% improvement in International Prostate Symptom Scores (IPSS) without repeat intervention, will be compared against a performance goal of 60% at 1 year.
Ancillary Efficacy Endpoints
Freedom from repeat intervention including repeat dilation (rods/bougies/dilators/balloons), urethrotomy, urethroplasty, or intermittent self-dilation by Kaplan-Meier analysis.
Symptom improvement measured by the IPSS questionnaire and USS PROM questionnaires will be summarized by descriptive statistics at each follow-up timepoint.
Functional improvement measured by peak urinary flow rate (Qmax).
Safety Endpoints
Primary Safety Endpoint
The rate of treatment related serious adverse events (SAEs) through 3 months post-treatment will be summarized with descriptive statistics.
Ancillary Safety Endpoint
Frequency and severity of treatment related complications graded by Clavien-Dindo severity scores (Dindo D, 2004).
Follow-up Visits and Length of Follow-up Clinical follow-up is anticipated to be conducted at 3 months, 6 months, and 1 year post-procedure, and annually thereafter through 5 years


URINATE PAS (PR1276) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/03/2022 06/03/2022 On Time
1 year report 12/03/2022 11/29/2022 On Time
18 month report 06/03/2023 06/01/2023 On Time
2 year report 12/03/2023 11/29/2023 On Time
3 year report 12/02/2024 12/02/2024 On Time
4 year report 12/02/2025    


Contact Us

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

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