OrganOx Metra® New Enrollment PAS

OrganOx Ltd.315 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

315

Conditions

Liver Transplantation

Interventions

Transplant with normothermic machine perfused (NMP) donor liverDEVICE

The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

Adverse biliary-related events

Adverse biliary-related events as measured by biliary complications

Time frame: 12-months post-transplant

Secondary Outcomes

Graft survival

Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant

Time frame: 12-months post-transplant

Subject survival

Subject survival post-liver transplant

Time frame: 12-months post-transplant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.