Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry

• Sponsor: TransMedics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05940857
• Collaborator: (none)
• Enrollment: 10,000
• Anticipated Duration (Months): 121

Study Details

Study Description

Brief Summary

OLP-II Registry is a sponsor-initiated, multi-center, observational, post-approval registry.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant	Device: OCS Liver

Detailed Description

The objective of the sponsor-initiated OLP-II Registry is to collect data on the post-transplant clinical outcomes of donor livers preserved and assessed on OCS Liver System and to document performance of the OCS device in the realworld setting.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 10000 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Sep 30, 2029
• Anticipated Study Completion Date: Oct 30, 2033

Arms and Interventions

Arm	Intervention/Treatment
OCS Liver Transplant Recipients All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry. Up to 10,000 subjects will be enrolled.	Device: OCS Liver; The TransMedics® Organ Care System (OCSTM) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.

Outcome Measures

Primary Outcome Measures

1. Survival [1-year]

   1-year patient survival with the originally transplanted liver (patient and graft survival) post-liver transplant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• TransMedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TransMedics
• ClinicalTrials.gov Identifier: NCT05940857
• Other Study ID Numbers: OCS-LIVER-OLP-II
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jul 11, 2023