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OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096754
Recruitment Status : Active, not recruiting
First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.

Condition or disease Intervention/treatment
Liver Transplant Device: OCS Liver

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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Intervention Details:
  • Device: OCS Liver
    Transplant with an OCS preserved liver.


Primary Outcome Measures :
  1. Graft Survival [ Time Frame: 24 Months ]
    Liver Graft Survival at 24 months post-transplant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects transplanted in the OCS Liver PROTECT CAP
Criteria

Inclusion Criteria:

  • Subjects transplanted in the OCS Liver PROTECT CAP

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096754


Locations
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United States, California
Scripps
La Jolla, California, United States, 92037
University of California San Diego
La Jolla, California, United States, 92037
University of California San Francisco
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Mount Sinai
New York, New York, United States, 10029
United States, Texas
University of Texas Southwest
Dallas, Texas, United States, 75390
Houston Methodist Hospital
Houston, Texas, United States, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT05096754    
Other Study ID Numbers: OCS-LVR-02-PAS
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes