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OrganOx Metra® New Enrollment PAS | Clinical Trials | Clareo Health

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COMPLETEDNCT05526326

OrganOx Metra® New Enrollment PAS

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 acc...

Lead sponsor: OrganOx Ltd.•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

OrganOx Ltd.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 3, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment315

Start dateNov 2022

Last updatedApr 3, 2025

Condition

Liver Transplantation

Locations shown

Medstar Georgetown University Hospital

Washington D.C., District of Columbia

Tampa General Hospital

Tampa, Florida

Loyola University

Maywood, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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