Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04792632
Status:
UNKNOWN
Last Update Posted:
2021-03-11
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance Evaluation of Veye Lung Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Growth assessment accuracy', 'timeFrame': '1 month', 'description': 'Demonstrate that the accuracy for determining volume change of actionable pulmonary nodules by the device is non-inferior to expert radiologists'}, {'measure': 'Composition classification accuracy', 'timeFrame': '2 months', 'description': 'Demonstrate that the accuracy for classifying the composition of actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)'}], 'primaryOutcomes': [{'measure': 'Detection accuracy', 'timeFrame': '2 months', 'description': 'Demonstrate that the accuracy for detecting actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)'}], 'secondaryOutcomes': [{'measure': 'Segmentation accuracy', 'timeFrame': '1 month', 'description': 'Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung; Node']}, 'descriptionModule': {'briefSummary': 'Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans.\n\nThis clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'US adult population that received a CT chest scan either as part of a lung cancer screening program or during routine practice', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects that underwent a CT chest scan for either lung cancer screening or routine practice\n\nExclusion Criteria:\n\n* Subjects with \\>10 pulmonary nodules;\n* Subjects with pulmonary mass(es) = largest axial diameter \\>30mm;\n* Subjects with interstitial lung disease.'}, 'identificationModule': {'nctId': 'NCT04792632', 'acronym': 'CPEVLN', 'briefTitle': 'Clinical Performance Evaluation of Veye Lung Nodules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aidence'}, 'officialTitle': 'Clinical Performance Evaluation of Veye Lung Nodules', 'orgStudyIdInfo': {'id': 'Aidence01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': 'Intervention is the use of Veye Lung Nodules during the reading of the CT scans', 'interventionNames': ['Device: Veye Lung nodules']}], 'interventions': [{'name': 'Veye Lung nodules', 'type': 'DEVICE', 'description': 'Veye Lung Nodules', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01740', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Central Contact', 'role': 'CONTACT', 'email': 'Contact@IntrinsicImaging.com', 'phone': '978-634-2200'}], 'facility': 'Intrinsic Imaging', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Joris Wakkie, Ms', 'role': 'CONTACT', 'email': 'joris@aidence.com', 'phone': '+31624561754'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aidence', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}