- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096754
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
December 7, 2023 updated by: TransMedics
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
Study Overview
Study Type
Observational
Enrollment (Actual)
74
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
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California
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La Jolla, California, United States, 92037
- University of California San Diego
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La Jolla, California, United States, 92037
- Scripps
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San Francisco, California, United States, 94143
- University of California San Francisco
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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-
New York
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New York, New York, United States, 10029
- Mount Sinai
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwest
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University Health System
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-
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 CAP
Description
Inclusion Criteria:
- Subjects transplanted in the OCS Liver PROTECT CAP
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft Survival
Time Frame: 24 Months
|
Liver Graft Survival at 24 months post-transplant.
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 3, 2020
Primary Completion (Actual)
February 2, 2023
Study Completion (Actual)
February 2, 2023
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 (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- OCS-LVR-02-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
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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