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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 Study Pending
Application Number P200031 / PAS003
Date Current Protocol Accepted  
Study Name OLP New Enrollment PAS
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 Design Description 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 Description 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).



Data Collection 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


OLP New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/28/2022    
1 year report 09/28/2022    


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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