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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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New Enrollment PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P200035 / PAS003
Date Original Protocol Accepted 12/09/2021
Date Current Protocol Accepted 07/07/2022
Study Name New Enrollment PAS
Device Name OrganOx metra System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives New Enrollment Study
This is a multi-site, single arm, unblinded post-approval study comparing prospective recipients of PAS NMP livers versus historical IDE SCS livers with respect to adverse biliary-related events.

Study Population Deceased DBD and DCD donor livers and adult liver transplant recipients.

Sample Size It is expected that NMP will be non-inferior to SCS in terms of biliary complications. The US IDE study demonstrated a biliary complication rate of 16% in 126 SCS subjects and 12% in 38 NMP subjects enrolled after enhanced training. Based on these data, this study has greater than 90% power for a noninferiority margin of 7.5%, assuming the population biliary complication rate for NMP in the PAS is 12%. The sample size estimate is based on a one-sided significance level of 0.05. The pooled Z-test is the test statistic. The final sample size of 285 livers, will be achieved by transplanting approximately 315 livers (assuming approximately 10% attrition).
Of the 315 transplanted livers, it will be ensured that at least 40 livers will be from DCD donors, to be able to summarize the outcomes of this subgroup in a meaningful way. With 40 DCD livers, the study will have an approximately 95% probability of observing one or more rare events of interest for events that occur at a population rate as low as 7.2%. Further, if there are zero events in the group of 40 DCD livers, the upper bound of the two-sided 95% exact binomial confidence bound would be 8.8%. If enrollment of 275 transplanted DBD livers is reached before 40 transplanted DCD livers are enrolled, enrollment will be limited to DCD livers until enrollment is complete.
Key Study Endpoints Primary Objective
To compare the effect of NMP to SCS in the prevention of adverse biliary-related events.

Secondary Objectives
To assess graft survival in new enrollment NMP livers.
To assess subject survival in new enrollment NMP livers.

Follow-up Visits and Length of Follow-up It is estimated 36 months recruitment and 12 months follow up.



New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/07/2023    


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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