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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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OLP New Enrollment PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P200031 / PAS003
Date Original Protocol Accepted 09/28/2021
Date Current Protocol Accepted  
Study Name OLP New Enrollment PAS
Device Name Organ Care System (OCS™) Liver
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
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 A prospective, single-arm, multi-center, new enrollment PAS designed to evaluate the short- and long-term safety and effectiveness of the OCS Liver System for DBD and DCD donor livers preserved on OCS according to the approved indication, in real-world use. The study will include all liver transplant centers in the U.S. that will commercially use the OCS Liver System, with a minimum of 15 participating sites.

Study Population Adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and eligibility criteria

Sample Size PAS will enroll the initial 160 sequential adult primary liver transplant recipients who are transplanted with an OCS-perfused DBD or DCD donor liver according to the approved indication (primary analysis population). If the initial 160 transplant recipients does not include at least 60 DCD donor liver transplants, PAS will continue to enroll only DCD donor liver recipients until 60 DCD patients have been enrolled.

For the primary endpoint (1-year patient and graft survival), a sample size of 107 subjects provides 80% power (with a one-sided alpha of 0.05).

For the safety endpoint (6-month graft survival), a sample size of 70 subjects provides 80% power (with a one-sided alpha of 0.05).

Key Study Endpoints Primary Endpoint: 1-year patient and graft survival post-transplant

Safety Endpoint: 6-month liver graft survival post-transplant

Other Clinical Endpoints:
Incidence of ischemic, non-anastomotic biliary complications through 1-year post-transplant
Incidence of non-ischemic, anastomotic biliary complications through 6 months post-transplant
Kaplan-Meier patient survival at 1- and 2-years
Kaplan-Meier graft survival at 6 months, 1- and 2-years

Collection of OCS Liver Related Data:
OCS Liver perfusion parameters (hepatic artery flow and pressure, portal vein flow and pressure, perfusate temperature, perfusate hematocrit, perfusate venous saturation)
OCS Liver perfusion lactate levels
OCS Liver perfusate pH values
Total bile volume at end of OCS liver perfusion
Incidence of and clinical reasons for donor liver turndown
Incidence and reasons for conversion to cold storage
Device malfunctions
Utilization rate
Follow-up Visits and Length of Follow-up 2 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 33
Actual Number of Sites Enrolled 4
Patient Follow-up Rate 100%
Study Strengths & Weaknesses Strength and weaknesses will be evaluate at the final report.


OLP New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/28/2022 03/16/2022 On Time
1 year report 09/28/2022 09/27/2022 On Time
18 month report 03/28/2023    
2 year report 09/28/2023    


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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