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NCT05940857 Clinical Trial

Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry

Liver Transplant Clinical Trial

— OLP-II  

Official title:
Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05940857
Other study ID # OCS-LIVER-OLP-II
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2023
Est. completion date September 2033

Study information
Verified date April 2024
Source TransMedics
Contact Kelly Jork
Phone 978-494-3918
Email kjork@transmedics.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

OLP-II Registry is a sponsor-initiated, multi-center, observational, post-approval registry.

Description:

The objective of the sponsor-initiated OLP-II Registry is to collect data on the post-transplant clinical outcomes of donor livers preserved and assessed on OCS Liver System and to document performance of the OCS device in the realworld setting.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date September 2033
Est. primary completion date September 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OCS Liver
The TransMedics® Organ Care System (OCSTM) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.

Locations
Country Name City State
United States University of Michigan Medical Center Ann Arbor Michigan
United States Emory University Hospital Atlanta Georgia
United States University of Alabama Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Lahey Clinic Medical Center Burlington Massachusetts
United States Carolinas Medical Center/Atrium Health Charlotte North Carolina
United States UT Southwestern Medical Center Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States Duke Medical Center Durham North Carolina
United States Houston Methodist Houston Texas
United States Mayo Clinic Hospital Florida Jacksonville Florida
United States University of California San Diego La Jolla California
United States NY Presbyterian Hospital/Columbia Univ. Medical Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Mayo Clinic Hospital Arizona Phoenix Arizona
United States SSM Health Saint Louis University Hospital Saint Louis Missouri
United States University Hospital, University of Texas Health Science Center 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 Survival 1-year patient survival with the originally transplanted liver (patient and graft survival) post-liver transplant. 1-year
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