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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05940857
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
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Brief Summary:
OLP-II Registry is a sponsor-initiated, multi-center, observational, post-approval registry.

Condition or disease Intervention/treatment
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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : September 2029
Estimated Study Completion Date : September 2033

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Survival [ Time Frame: 1-year ]
    1-year patient survival with the originally transplanted liver (patient and graft survival) post-liver transplant.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria
All liver transplant recipients who are transplanted with an OCS-perfused donor liver are eligible for the Registry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05940857


Contacts
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Contact: Kelly Jork 978-494-3918 kjork@transmedics.com
Contact: Kausar Qidwai kqidwai@transmedics.com

Locations
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Sponsors and Collaborators
TransMedics
More Information
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT05940857    
Other Study ID Numbers: OCS-LIVER-OLP-II
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024

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