Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-31 @ 3:28 AM
Study NCT ID:
NCT03868904
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2019-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INSPIRE Continuation Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-07', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brochiolitis Obliterans Syndrome (BOS) -free survival', 'timeFrame': '5 years post transplant', 'description': 'BOS-free survival'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '5 years', 'description': 'Survival post transplant'}, {'measure': "Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)", 'timeFrame': '5 years', 'description': 'Freedom from BOS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bronchiolitis Obliterans']}, 'descriptionModule': {'briefSummary': 'To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who participated in TransMedics OCS Lung System INSPIRE Trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in TransMedics OCS Lung System INSPIRE trial\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03868904', 'briefTitle': 'INSPIRE Continuation Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransMedics'}, 'officialTitle': 'OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS', 'orgStudyIdInfo': {'id': 'OCS-LUN-03-PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OCS Lung INSPIRE Trial', 'interventionNames': ['Device: OCS Lung System']}], 'interventions': [{'name': 'OCS Lung System', 'type': 'DEVICE', 'description': 'No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial.', 'armGroupLabels': ['OCS Lung INSPIRE Trial']}]}, '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 at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'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': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University of Leuven Hospital', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'N.H.C Hospital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Institute Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-300625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University of Padua', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '25222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta De Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'UB9 6JH', 'city': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Harefield Hospital', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransMedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}