Not Yet RecruitingNot Applicable

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

215 participantsStarted 2027-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Participant is willing to comply with the study requirements and procedures

Exclusion criteria

✕. 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

What they're measuring

Incidence of Early Allograft Dysfunction

Timeframe: Day 7 (post operative)

Overall graft survival

Timeframe: Day 180 (post operative)

Trial details

NCT IDNCT06916325

SponsorXVIVO Perfusion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Jaya Tiwari

240-758-3818 jaya.tiwari@xvivogroup.com

View on ClinicalTrials.gov More Liver Transplant Surgery trials