Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04194437
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2019-12-09
Brief Title:
OCS Liver DCD Trial
Sponsor:
TransMedics
Organization:
TransMedics
Study Overview
Official Title:
Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System OCS Liver for Preserving Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
Evaluate the safety and effectiveness of the OCS Liver System to preserve optimize the condition and assess levers from DCD donors
Detailed Description:
To evaluate the safety and effectiveness of the OCS Liver to preserve optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None