Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-07 @ 10:19 PM
Study NCT ID:
NCT03310905
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Wall Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with a viable abdominal wall transplant at 18 months', 'timeFrame': 'up to 18 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Research', 'Transplant', 'Abdominal Wall', 'Hernia'], 'conditions': ['Transplant;Failure,Kidney', 'Transplant; Failure, Liver', 'Transplant; Failure, Bowel', 'Abdominal Wall Defect', 'Abdominal Wall Fistula', 'Abdominal Wall Hernia', 'Abdominal Wall Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.', 'detailedDescription': 'Within this protocol we propose to perform abdominal wall transplantation in 5 subjects, either as an isolated abdominal wall or in combination with another organ transplant. Each subject will be followed for a study period of 18 months.\n\nParticipants receiving an isolated abdominal wall or abdominal wall in combination with another organ transplant will receive the standard immunosuppression therapy as the non-vascularized composite allograft organ transplant. These patients will be studied to determine efficacy of the abdominal wall transplant to restore function of the defective abdominal wall for a study period of 18 months at Duke University Medical Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates between 18-65 years old\n* Willingness and legal ability to give consent\n* Abdominal Wall in combination with another organ transplant: they must be eligible for the non-vascularized composite allograft organ transplant at Duke\n\nExclusion Criteria:\n\n* Malignancy at evaluation or history of malignancy that precludes transplantation\n* Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.\n* Medical exclusion criteria for general anesthesia\n* Ongoing substance abuse or history of untreated substance abuse'}, 'identificationModule': {'nctId': 'NCT03310905', 'briefTitle': 'Abdominal Wall Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Abdominal Wall Transplantation for the Reconstruction of Abdominal Wall Defects as Adjunct to Abdominal Solid Organ Transplantation', 'orgStudyIdInfo': {'id': 'Pro00084054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isolated Abdominal Wall Transplant', 'interventionNames': ['Procedure: Abdominal Wall Transplant alone']}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal Wall with Solid Organ Transplant', 'interventionNames': ['Procedure: Abdominal Wall Transplant with another solid organ transplant']}], 'interventions': [{'name': 'Abdominal Wall Transplant with another solid organ transplant', 'type': 'PROCEDURE', 'description': 'Transplant of abdominal wall in combination with another solid organ transplant.', 'armGroupLabels': ['Abdominal Wall with Solid Organ Transplant']}, {'name': 'Abdominal Wall Transplant alone', 'type': 'PROCEDURE', 'description': 'Abdominal Wall Transplant alone', 'armGroupLabels': ['Isolated Abdominal Wall Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Linda Cendales, MD', 'role': 'CONTACT', 'email': 'linda.cendales@duke.edu', 'phone': '919-681-7514'}, {'name': 'Kadiyala Ravindra, MD', 'role': 'CONTACT', 'email': 'kadiyala.ravindra@duke.edu', 'phone': '919-613-9687'}], 'overallOfficials': [{'name': 'Linda Cendales, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Kadiyala Ravindra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'At this time all data will be de-identified and there is no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linda Cendales, MD', 'class': 'UNKNOWN'}, {'name': 'Kadiyala Ravindra, M.D.', 'class': 'UNKNOWN'}, {'name': 'Detlev Erdmann, M.D.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}