OrganOx Metra® New Enrollment PAS

Launched by ORGANOX LTD. · Aug 31, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

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 (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.