OCS Liver PROTECT Continuation Post-Approval Study

January 7, 2024 updated by: TransMedics
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • San Diego, California, United States, 92121
        • Scripps
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • University of Tennessee Health Science Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwest
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health System
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects transplanted in the OCS Liver PROTECT Trial

Description

Inclusion Criteria:

  • Subjects transplanted in the OCS Liver PROTECT Trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
OCS Liver
Device: OCS Liver
Transplanted with a OCS preserved liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Graft Survival
Time Frame: 2 years
Liver Graft Survival through 2 years (24 months) after transplantation.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Survival
Time Frame: 2 years
Patient Survival (freedom from mortality) through 2 years (24 months) after transplantation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransMedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2016

Primary Completion (Actual)

November 5, 2021

Study Completion (Actual)

November 5, 2021

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • OCS-LVR-01-PAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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