[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586511":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":20,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":20,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":20,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"XVIVO Perfusion","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants requiring liver transplant","EXPERIMENTAL","Extended criteria donor donation after brain death (ECD-DBD) or donation after circulatory death (DCD) donor organs will be recovered, transported via static cold storage (SCS), and undergo dual hypothermic oxygenated perfusion (DHOPE) on Liver Assist.",[13],"Device: dual hypothermic oxygenated perfusion (DHOPE)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","dual hypothermic oxygenated perfusion (DHOPE)","Clinically, end-ischemic DHOPE has been shown to restore hepatic ATP, reduce reperfusion injury, and improve outcomes after deceased donor liver transplantation. Recent prospective and retrospective clinical studies detail the safety and feasibility of prolonged preservation of donor livers with DHOPE for up to 20 hours; prolonged perfusion has shown similarly low rates of serious adverse events, a potential protective effect in mitigating acute kidney injury and may facilitate decreased frequency of discarded and nonuse of donor livers.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jaya Tiwari","CONTACT","240-758-3818","jaya.tiwari@xvivogroup.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100586511","open-label-trial-of-deceased-donor-livers-transplanted-after-dhope-with-exvivo-liver-perfusion-100586511",false,"NCT06916325","Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","Participant Inclusion Criteria:\n\n1. Participant is able to provide informed consent and HIPAA authorization\n2. Age ≥18 years\n3. 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\n\n   \\- 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\n4. Participant is willing to comply with the study requirements and procedures\n\nParticipant Exclusion Criteria:\n\n1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)\n2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)\n3. Participant is listed for a repeat liver transplantation (\\>1 graft)\n4. Participant is pregnant\n5. Participant is on respiratory (ventilator dependent) and\u002For cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)\n6. Participant is enrolled in an interventional clinical trial with an investigational drug or device\n7. 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","ALL","18 Years",{"count":39,"type":40},215,"ESTIMATED","INTERVENTIONAL",[43],"NA","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.",[46,47],"Liver Transplant Surgery","Liver Transplantation","NOT_YET_RECRUITING","2026-04-16",{"date":51,"type":52},"2026-04-21","ACTUAL",{"date":54,"type":40},"2027-01",{"date":56,"type":40},"2033-04",{"name":5,"class":6}]