OrganOx Metra® New Enrollment PAS

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.

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.

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.