WP02 Continued Access Study

NCT04862156 | Terminated Results DMC FDA Device

• 1 other identifier: WP02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of Early Allograft Dysfunction (EAD)

  Severity of immediate graft injury as measured by early allograft dysfunction (EAD).

  7 days

Study Arms (1)

Normothermic Machine Perfusion (NMP)

EXPERIMENTAL

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.

Device: Normothermic Machine Perfusion (NMP)

Interventions

Normothermic Machine Perfusion (NMP) DEVICE

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

Also known as: OrganOx metra device

Normothermic Machine Perfusion (NMP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject requiring all of the following at the time of transplantation:
• Oxygen therapy via a ventilator/respirator
• Inotropic support
• 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.

Sponsors & Collaborators

• OrganOx Ltd.: lead
• North American Science Associates Ltd.: collaborator

Study Sites (7)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Limitations and Caveats

The study was terminated and the 19 subjects were included in the New Enrollment PAS study (NCT05526326)

Results Point of Contact

• Title: Katerina de Metz
• Organization: OrganOx

katerina.demetz@organox.com

19713442167

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 27, 2021
• Study Start: October 10, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 7, 2023
• Last Updated: April 15, 2025
• Results First Posted: November 29, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)