OrganOx Metra® New Enrollment PAS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-10

Study Completion Date

2025-02-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Transplant with normothermic machine perfused (NMP) donor liver

Intervention Type DEVICE

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

Interventions

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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®

Intervention Type DEVICE

Other Intervention Names

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OrganOx metra® normothermic machine perfusion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No