NCT05526326
OrganOx Metra® New Enrollment PAS
ACTIVE_NOT_RECRUITING
NCT05526326
OBSERVATIONAL
OrganOx Metra® New Enrollment Post-Approval Study
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.
Inclusion Criteria:
* Subject is 18 years of age or greater
* Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
* Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements (in the opinion of the Investigator)
Exclusion Criteria:
* Subject requiring all of the following at the time of transplantation:
1. Oxygen therapy via a ventilator/respirator
2. Inotropic support
3. Renal replacement therapy
* Subject has acute/fulminant liver failure (UNOS status 1A)
* Subject planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
* Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
* Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.
Liver Transplantation
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- Type: DEVICE
- Name: Transplant with normothermic machine perfused (NMP) donor liver
- Description: The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®
- Arm Group Labels: Post-Approval Transplant Recipient cohort
- OrganOx Ltd.