NCT05526326

OrganOx Metra® New Enrollment PAS

OrganOx Metra® New Enrollment Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 315 (actual)
• Sponsor: OrganOx Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
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®

Timeline

• Start date: 2022-11-10
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2022-09-02
• Last updated: 2025-04-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study