Status:
NOT_YET_RECRUITING
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
Lead Sponsor:
XVIVO Perfusion
Conditions:
Liver Transplant Surgery
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantat...
Eligibility Criteria
Inclusion
- Participant
- Participant is able to provide informed consent and HIPAA authorization
- Age ≥18 years
- Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation
- \- For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant
- Participant is willing to comply with the study requirements and procedures
- Participant
Exclusion
- Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)
- Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
- Participant is listed for a repeat liver transplantation (\>1 graft)
- Participant is pregnant
- Participant is on respiratory (ventilator dependent) and/or cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)
- Participant is enrolled in an interventional clinical trial with an investigational drug or device
- Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT06916325
Start Date
July 1 2025
End Date
January 1 2032
Last Update
April 8 2025
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