US National OCS Liver Perfusion (OLP) Registry
NCT05940857 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100000
Last updated 2024-08-16
Summary
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.
Conditions
- Liver Transplant
Interventions
- DEVICE
-
OCS Liver
The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.
Sponsors & Collaborators
-
TransMedics
lead INDUSTRY
Principal Investigators
-
Ahmed Elbetanony, MD · TransMedics
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-14
- Primary Completion
- 2031-10-31
- Completion
- 2031-10-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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