Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:27 AM
Study NCT ID:
NCT07361718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance rate to transplant', 'timeFrame': 'after the transplant'}], 'secondaryOutcomes': [{'measure': 'days on mechanical ventilation', 'timeFrame': 'from transplant moment since the day weaning from mechanical ventilation'}, {'measure': 'duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)', 'timeFrame': 'from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)'}, {'measure': 'mortality', 'timeFrame': 'within 90 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.', 'detailedDescription': "Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are:\n\nOrgan Care System (OCS) Transmedics, a mobile machine for use at the donor site.\n\nXPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than 18 years\n* informed consent\n* donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification\n\nExclusion Criteria:\n\n* lung Haematoma or signsd of lung contusion\n* signs of infecton of the graft'}, 'identificationModule': {'nctId': 'NCT07361718', 'acronym': 'EVOLUTION', 'briefTitle': 'Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)', 'orgStudyIdInfo': {'id': '697/2024/Disp/AOUBo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS', 'interventionNames': ['Device: Organ Care system']}, {'type': 'EXPERIMENTAL', 'label': 'X vivo', 'interventionNames': ['Device: ex vivo lung perfusion for eventual lung transplant']}], 'interventions': [{'name': 'ex vivo lung perfusion for eventual lung transplant', 'type': 'DEVICE', 'description': 'ex vivo lung repefusion to evaluate lung function', 'armGroupLabels': ['X vivo']}, {'name': 'Organ Care system', 'type': 'DEVICE', 'description': 'organ care system', 'armGroupLabels': ['OCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Irccs Aoubo', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Filippo FA Antonacci, MD', 'role': 'CONTACT', 'email': 'filippo.antonacci@aosp.bo.it', 'phone': '+390512145593'}, {'name': 'Melania MM Milanese, Pharmacy', 'role': 'CONTACT', 'email': 'melania.milanese@aosp.bo.it'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Filippo Antonacci', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}