Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OrganOx Ltd.
The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
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.
