Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation

OrganOx Ltd.7 sites in 1 country19 target enrollmentOctober 10, 2021

ConditionsLiver Transplantation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Liver Transplantation
Sponsor: OrganOx Ltd.
Enrollment: 19
Locations: 7
Primary Endpoint: Incidence of Early Allograft Dysfunction (EAD)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 10, 2021

End Date

July 7, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

OrganOx Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.