WP02 Continued Access Study

OrganOx

Status: Terminated

Conditions: Liver Transplantation

Treatments: Device: Normothermic Machine Perfusion (NMP)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04862156

WP02

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Normothermic Machine Perfusion (NMP)

Experimental group

Description:

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.

Treatment:

Device: Normothermic Machine Perfusion (NMP)