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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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Extended Follow-up of the Premarket Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number
P210034 / PAS001
Date Original Protocol Accepted 03/29/2022
Date Current Protocol Accepted  
Study Name Extended Follow-up of the Premarket Cohort
Device Name Agili-C
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, open-label, randomized 2:1, and controlled trial of Agili-C™ vs. SSOC for the repair of joint surface lesions.
Study Population Patients with joint surface lesions of the knee
Sample Size Up to 251 subjects (167 Agili-C™ subjects and 84 SSOC subjects) who were enrolled into the Pivotal study and are continuing follow up.
Key Study Endpoints Primary Endpoint:
Change from baseline to 60 months in the average overall KOOS score (Pain, Symptoms, QOL, ADL & Sports)

Safety Endpoint:
Adverse events, including serious adverse events, reoperations and revisions, up to 60 months

Confirmatory Secondary endpoints:
This trial will have one primary endpoint and 6 confirmatory secondary endpoints for labeling purposes. These will be tested sequentially, and Type I Error controlled hierarchically. Trial success will be declared if the primary endpoint has been met. Additional labeling claims will be made for confirmatory secondary endpoints met in sequence following success on the primary endpoint:
Change from baseline to 60 months in the average overall KOOS score (Pain, Symptoms, QOL, ADL & Sports)

Additional Secondary endpoints:
KOOS subscores, MRI defect fill %, IKDC, SF-12, Tegner, Lysolm, subgroup analyses.
Follow-up Visits and Length of Follow-up 60 months (5 years) post-implant


Extended Follow-up of the Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/28/2022 10/26/2022 On Time
2 year report 10/30/2023    
3 year report 10/30/2024    
final report 03/31/2025    


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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