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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PROTECT CAP Continuation PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P200031 / PAS002
Date Original Protocol Accepted 09/28/2021
Date Current Protocol Accepted  
Study Name PROTECT CAP Continuation PAS
Device Name Organ Care System (OCS™) Liver
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This single-arm study is a continued follow-up of the OCS Liver PROTECT Continued Access Protocol (CAP) cohort (premarket), designed to evaluate longer-term outcomes after transplantation with OCS-perfused livers
Study Population Patients who were transplanted in the OCS Liver PROTECT CAP study
Sample Size 74 patients who were transplanted in the PROTECT CAP study
Key Study Endpoints Main effectiveness endpoint: Liver graft survival at 24 months post-transplant

Other endpoint: patient survival at 24 months post-transplant
Follow-up Visits and Length of Follow-up 2 years
Interim or Final Data Summary
Actual Number of Patients Enrolled The PROTECT CAP trial (premarket) enrolled 74 subjects and these subjects are being followed in this PAS.
Actual Number of Sites Enrolled The PROTECT CAP trial (premarket) included 11 sites which enrolled patients and all these sites were participating in this PAS.
Patient Follow-up Rate Month 6 - 93.2%, Month 12 - 90.5, Month 24 - 86.4%
Final Safety Findings 10 deaths have occurred, including one (1) during this reporting period. None of them were procedure or device related.
There have been no additional retransplants since PMA approval.
No other adverse events were reported.
Final Effect Findings Kaplan-Meyer (K-M) graft survival for Protect CAP Patients shows the following:
Patient’s Non-Survival Events occurred in1.4% (1/69) at 6 months, 1.5% (1/65) at 12 months, and 3.6% (1/28) at 24 months.
Graft survival remained high at 96.4% at 24 months (27/28).
Study Strengths & Weaknesses There have been no additional retransplants since PMA approval.
Recommendations for Labeling Changes The study elements of this PAS must be included in the labeling, including the study design, specific aims, study outcomes, study population, inclusion and exclusion criteria, statistical analysis, results, and discussion including how the conditions of approval were met


PROTECT CAP Continuation PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/28/2022 03/15/2022 On Time
1 year report 09/28/2022 09/02/2022 On Time
18 month report 03/28/2023 03/03/2023 On Time
final report 06/30/2023 06/14/2023 On Time


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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