Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05074160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2021-09-29
Brief Title:
OCS Liver Perfusion OLP Post-Approval Registry
Sponsor:
TransMedics
Organization:
TransMedics
Study Overview
Official Title:
OCS Liver Perfusion OLP Post-Approval Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting
Detailed Description:
OLP Registry is a multi-center observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None