Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-27 @ 2:18 PM
Study NCT ID:
NCT03343535
Status:
TERMINATED
Last Update Posted:
2024-02-28
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OCS Lung System EXPAND II Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ldamme@transmedics.com', 'phone': '978-552-0900', 'title': 'VP, Clinical Affairs', 'organization': 'TransMedics, Inc.'}, 'certainAgreement': {'otherDetails': "Site shall have right to publish results. To balance this right with TransMedics' (TM proprietary interests, site will submit manuscripts intended for publication for TM's review at least 30d prior to submission date. TM will complete its review within 30d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients.', 'description': 'Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 12, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'Respiratory failure/protracted ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Major pulmonary-related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial anastomotic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biopsy-proven moderate or severe acute rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant', 'description': 'Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Donor Lung Utilization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}, {'units': 'Lungs Instrumented on OCS', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Immediately at Transplantation', 'description': 'Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.', 'unitOfMeasure': 'Lungs Instrumented on OCS', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lungs Instrumented on OCS', 'denomUnitsSelected': 'Lungs Instrumented on OCS', 'populationDescription': '51 eligible donor lungs were instrumented on OCS. 46 donor lungs were accepted after perfusion and transplanted into recipients.'}, {'type': 'SECONDARY', 'title': 'Primary Graft Dysfunction Grade 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hours post-transplant', 'description': 'Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Lung Graft-related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant', 'description': 'Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Donor Lungs Transplanted', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'comment': '36-month follow-up completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Subject Discontinued Due to Re-transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': '51 Donor Lungs were instrumented on OCS Lung and 46 Donor Lungs were accepted and transplanted on study.', 'preAssignmentDetails': 'Enrollment was stopped as a result of the FDA Approval of OCS Lung for the EXPAND indication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OCS Preservation', 'description': 'OCS Lung Preservation: OCS Lung Preservation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Recipient Age (years)', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Recipient Gender', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-18', 'size': 3835292, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-18T16:47', 'hasProtocol': True}, {'date': '2017-12-18', 'size': 5253166, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-18T16:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'OCS Lung System'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2017-11-08', 'resultsFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-01', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Lung Graft-related Serious Adverse Events', 'timeFrame': '30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant', 'description': 'Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject.'}], 'primaryOutcomes': [{'measure': 'Patient Survival', 'timeFrame': '30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant', 'description': 'Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.'}, {'measure': 'Donor Lung Utilization Rate', 'timeFrame': 'Immediately at Transplantation', 'description': 'Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.'}], 'secondaryOutcomes': [{'measure': 'Primary Graft Dysfunction Grade 3', 'timeFrame': '72 hours post-transplant', 'description': 'Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['portable ex-vivo lung perfusion', 'breathing lung transplant', 'portable OCS Lung System'], 'conditions': ['Lung Transplantation']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.', 'detailedDescription': 'Inclusion\n\nAt least one of the following:\n\n* Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or\n* Expected cross-clamp time \\> 6 hours for the second lung; or\n* Donor after Cardiac Death (DCD donor); or\n* Donor age ≥ 55 years old'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female primary double lung transplant candidate\n* Age ≥ 18 years old\n* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information\n\nExclusion Criteria:\n\n* Prior solid organ or bone marrow transplant\n* Single lung recipient\n* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis\n* Participant in any other clinical or investigational trials/programs'}, 'identificationModule': {'nctId': 'NCT03343535', 'briefTitle': 'OCS Lung System EXPAND II Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation', 'orgStudyIdInfo': {'id': 'OCS-LUN-012017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS Preservation', 'interventionNames': ['Device: OCS Lung Preservation']}], 'interventions': [{'name': 'OCS Lung Preservation', 'type': 'DEVICE', 'otherNames': ['OCS Lung Transplant'], 'description': 'OCS Lung Preservation', 'armGroupLabels': ['OCS Preservation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor St. Luke's Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}