NCT05074160

OCS Liver Perfusion (OLP) Post-Approval Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.

Detailed description

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DEVICE	OCS Liver	Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Timeline

• Start date: 2021-10-14
• Primary completion: 2024-03-22
• Completion: 2026-06-01
• First posted: 2021-10-12
• Last updated: 2025-04-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study