FDA agreed that WP02 CAP could be stopped. The OrganOx metra device was approved on December 9, 2021. The 105 planned CAP patients will be included in the Post-Approval study (NCT05526326).

The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.

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

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 undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)

• Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing

• Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

1 year

The study was terminated and the 19 subjects were included in the New Enrollment PAS study (NCT05526326)