Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 6:22 PM
Study NCT ID:
NCT05940857
Status:
RECRUITING
Last Update Posted:
2024-08-16
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US National OCS Liver Perfusion (OLP) Registry
Sponsor:
TransMedics
Organization:
Study Overview
Official Title:
US National OCS Liver Perfusion (OLP) Registry
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
National OLP
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: