OrganOx Metra® New Enrollment PAS
Completed
Conditions studied: Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT05526326
- Run by
- OrganOx Ltd.
- People needed
- 315
- Starts
- 2022-11-10
- Expected to finish
- 2025-02-05
- Last updated by the study team
- 2025-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Subject requiring all of the following at the time of transplantation:
- Oxygen therapy via a ventilator/respirator
- Inotropic support
- 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.
Where it is running
- Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Tampa General Hospital — Tampa, Florida, United States
- Loyola University — Maywood, Illinois, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Mount Sinai — New York, New York, United States
- Duke University — Durham, North Carolina, United States
- The Ohio State University — Columbus, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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