Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06916325 | NOT YET RECRUITING | Liver Transplant Surgery

Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
Sponsor:

XVIVO Perfusion

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 transplantation.

Condition or disease

Liver Transplant Surgery

Liver Transplantation

Intervention/treatment

dual hypothermic oxygenated perfusion (DHOPE)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 215 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2032-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Participant Inclusion Criteria
  • 1. Participant is able to provide informed consent and HIPAA authorization
  • 2. Age ≥18 years
  • 3. 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
  • 4. Participant is willing to comply with the study requirements and procedures
  • Participant Exclusion Criteria
    • 1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)
    • 2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)
    • 3. Participant is listed for a repeat liver transplantation (\>1 graft)
    • 4. Participant is pregnant
    • 5. 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)
    • 6. Participant is enrolled in an interventional clinical trial with an investigational drug or device
    • 7. 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
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion

Location Details

NCT06916325

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found