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NCT05096754 Clinical Trial

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

Liver Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05096754
Other study ID # OCS-LVR-02-PAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2020
Est. completion date February 2, 2023

Study information
Verified date May 2023
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date February 2, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects transplanted in the OCS Liver PROTECT CAP

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Johns Hopkins Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States University of Texas Southwest Dallas Texas
United States Houston Methodist Hospital Houston Texas
United States Scripps La Jolla California
United States University of California San Diego La Jolla California
United States Mount Sinai New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Virginia Commonwealth University Health System Richmond Virginia
United States The University of Texas Health Science Center at San Antonio San Antonio Texas
United States University of California San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Graft Survival Liver Graft Survival at 24 months post-transplant. 24 Months
See also
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