WP02 Continued Access Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2023-07-07

Brief Summary

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The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normothermic Machine Perfusion (NMP)

Following the routine retrieval procedure of the liver, it will be placed on the OrganOx metra for Normothermic Machine Perfusion (NMP) for transport per the Investigational Plan and the Instructions for Use.

Group Type EXPERIMENTAL

Normothermic Machine Perfusion (NMP)

Intervention Type DEVICE

Storage and transportation of the donated liver using the OrganOx metra device.

Interventions

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Normothermic Machine Perfusion (NMP)

Storage and transportation of the donated liver using the OrganOx metra device.

Intervention Type DEVICE

Other Intervention Names

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OrganOx metra device

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

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 undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
* Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
* Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No