WP02 Continued Access Study

Not Applicable

Terminated

• Conditions: Liver Transplantation
• Interventions: Device: Normothermic Machine Perfusion (NMP)

• Registration Number: NCT04862156
• Lead Sponsor: OrganOx Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Study Start: 2021-10-10
• Primary Completion: 2022-07-31
• Study Completion: 2023-07-07
• Results First Submitted: 2023-11-07
• Results First Submitted QC: 2023-11-07
• Results First Posted: 2023-11-29
• Status Verified: 2024-01
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normothermic Machine Perfusion (NMP)	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Early Allograft Dysfunction (EAD)	7 days	Severity of immediate graft injury as measured by early allograft dysfunction (EAD).

Trial Locations

Locations (7)

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Loyola University Chicago; 🇺🇸 Maywood, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States