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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Device: Transplant with normothermic machine perfused (NMP) donor liver

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult primary liver transplant candidates on the waiting list for liver transplant at a U.S. liver transplant center and who meet the eligibility criteria at the participating study centers

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-Approval Transplant Recipient cohort; 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	Device: Transplant with normothermic machine perfused (NMP) donor liver; The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®; Other Names: OrganOx metra® normothermic machine perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse biliary-related events	Adverse biliary-related events as measured by biliary complications	12-months post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft survival	Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant	12-months post-transplant
Subject survival	Subject survival post-liver transplant	12-months post-transplant

Collaborators and Investigators

• Sponsor: OrganOx Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Liver transplantation; Normothermic perfusion; Biliary complications
• Other Study ID Numbers: P200035/PAS003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No