Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 4:25 PM
Study NCT ID:
NCT07102550
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biliary complications', 'timeFrame': '1 year post living donor liver transplant', 'description': 'Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Complication Rates', 'timeFrame': '1 year post living donor liver transplant', 'description': 'Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection'}, {'measure': 'Post-operative Hospital Length of Stay', 'timeFrame': 'From date of transplant until date of discharge from hospital, assessed up to 365 days', 'description': 'Hospital length of stay'}, {'measure': 'Post-operative ICU Length of Stay', 'timeFrame': 'From date of transplant until date of transfer out of ICU, assessed up to 365 days', 'description': 'ICU length of stay (days)'}, {'measure': 'Readmissions', 'timeFrame': '1 year post living donor liver transplant', 'description': 'Number of readmissions post-operatively'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Living Donor Liver Transplant', 'Liver Transplant Complications'], 'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.', 'detailedDescription': 'The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults. MiMedx placental tissue grafts are registered with the FDA for homologous use in any location in the body as a protective barrier that supports the healing cascade, which is the use the investigators intend it for in this trial.\n\nThe main questions this study aims to answer are:\n\n1. Can bile-duct reinforcement using MiMedx placental tissue grafting demonstrate equal-to-improved biliary complications in patients who are recipients of living donor liver transplant?\n2. What are the rates of postoperative complications and outcomes of living donor liver transplant after using MiMedx placental tissue grafting?\n\nParticipants will:\n\n1. undergo living donor liver transplant per standard procedures at Cleveland Clinic, including pre-procedure, post-procedure, and follow-up visits.\n2. consent to the placement of MiMedx placental tissue graft around the biliary anastomosis during their liver transplant.\n3. consent to allow the study team to perform a review of their medial records after each standard-of-care follow-up visit to assess presence of any biliary complications up to 1 year post-transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>/= 18 years old\n* Recipient of LDLT\n\nExclusion Criteria:\n\n* Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee.\n* Patients \\< 18 years old\n* Patients who cannot provide informed consent\n* Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT)\n* Patients who do not wish to participate\n* Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.'}, 'identificationModule': {'nctId': 'NCT07102550', 'briefTitle': 'Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '23-829'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Living Donor Liver Transplant (LDLT) graft recipient', 'description': 'LDLT recipient with MiMedx placental graft placement', 'interventionNames': ['Biological: MiMedx AmnioFix']}], 'interventions': [{'name': 'MiMedx AmnioFix', 'type': 'BIOLOGICAL', 'description': 'MiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.', 'armGroupLabels': ['Living Donor Liver Transplant (LDLT) graft recipient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erlind Allkushi', 'role': 'CONTACT', 'email': 'allkuse2@ccf.org', 'phone': '216-444-0223'}, {'name': 'Mary Bilancini', 'role': 'CONTACT', 'email': 'bilancm@ccf.org', 'phone': '2164448983'}, {'name': 'Choon Hyuck D Kwon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Erlind Allkushi', 'role': 'CONTACT', 'email': 'allkuse2@ccf.org', 'phone': '2164440223'}, {'name': 'Mary Bilancini', 'role': 'CONTACT', 'email': 'bilancm@ccf.org', 'phone': '2164448983'}], 'overallOfficials': [{'name': 'Choon Hyuck D Kwon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Choon Hyuck David Kwon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Choon Hyuck David Kwon', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}