OrganOx Metra® New Enrollment PAS

OrganOx

Status: Completed

Conditions: Liver Transplantation

Treatments: Device: Transplant with normothermic machine perfused (NMP) donor liver

Study type: Observational

Funder types: Industry

Identifiers

NCT05526326

P200035/PAS003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

315 participants in 1 patient group

Post-Approval Transplant Recipient cohort

Description:

Adult liver transplant recipients who are transplanted with an OrganOx metra® perfused DBD or DCD donor liver according to the approved indication and matching eligibility criteria

Treatment:

Device: Transplant with normothermic machine perfused (NMP) donor liver