OrganOx Metra® New Enrollment PAS

Liver Transplantation Clinical Trial

Official title:

OrganOx Metra® New Enrollment Post-Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05526326
• Other study ID #: P200035/PAS003
• Status: Active, not recruiting
• Start date: November 10, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: OrganOx Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current indications for use in the real-world setting.

Description:

The OrganOx metra® New Enrollment Post-Approval Study is a multi-site, single arm, unblinded post-approval study that will enroll deceased DBD or DCD donor liver and adult liver transplant recipients according to the current indication and that match the eligibility criteria below.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 315
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (in the opinion of the Investigator)

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 planned to undergo simultaneous transplantation of more than one organ (e.g., liver and kidney) from the same liver donor
• Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
• Concurrent enrollment in another clinical study. Subjects enrolled in clinical studies or registries where only measurements and/or samples are taken (no test device or test drug) are allowed to participate.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Transplant with normothermic machine perfused (NMP) donor liver
The enrolled recipient will receive a DBD or DCD donor liver that underwent normothermic machine perfusion with the OrganOx metra®

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	The Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Wisconsin	Madison	Wisconsin
United States	Loyola University	Maywood	Illinois
United States	Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
OrganOx Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse biliary-related events	Adverse biliary-related events as measured by biliary complications	12-months post-transplant
Secondary	Graft survival	Liver graft survival post-liver transplant as measured by the number of subjects needing a re-transplant	12-months post-transplant
Secondary	Subject survival	Subject survival post-liver transplant	12-months post-transplant