Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 12:25 AM
Study NCT ID:
NCT03856450
Status:
UNKNOWN
Last Update Posted:
2020-09-30
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-24', 'size': 588278, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-01T15:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of X-ray Images', 'timeFrame': '1 year', 'description': 'collection of image sets from X-ray imaging exams for each complete and evaluable subject case'}, {'measure': 'Number of DTS images', 'timeFrame': '1 year', 'description': 'Collection of image sets from DTS imaging exams for each complete and evaluable subject case'}, {'measure': 'Number of CT (or MRI) images', 'timeFrame': '1 year', 'description': 'collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case'}], 'secondaryOutcomes': [{'measure': 'Questionnaire about Diagnosis', 'timeFrame': '1 year', 'description': 'collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case'}, {'measure': 'Questionnaire about Treatment', 'timeFrame': '1 year', 'description': 'collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Distal Radius Fracture', 'Scaphoid Fracture']}, 'descriptionModule': {'briefSummary': 'The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.', 'detailedDescription': "The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Control-arm Subjects:\n\nSubjects who meet all of the following inclusion criteria may be enrolled in this study:\n\n1. Are adults aged 18 years or older;\n2. Are able and willing to comply with study procedures; and\n3. Are able and willing to provide written informed consent to participate in this study.\n\nExclusion Criteria for Control-arm Subjects:\n\nSubjects who meet any of the following exclusion criteria will be excluded from this study:\n\n1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;\n2. Have had known prior trauma in either wrist.\n\nInclusion Criteria for Test-arm Subjects:\n\nSubjects who meet all of the following inclusion criteria may be enrolled in this study:\n\n1. Are adults aged 18 years or older;\n2. Have a confirmed or suspected distal radius or scaphoid wrist fracture;\n3. Have completed an X-ray imaging exam per standard of care;\n4. Have a standard of care (SOC) CT or MRI exam ordered;\n5. Are able and willing to complete DTS imaging exam (if not already completed);\n6. Are able and willing to comply with study procedures; and\n7. Are able and willing to provide written informed consent to participate in this study.\n\nExclusion Criteria for Test-arm Subjects:\n\nSubjects who meet any of the following exclusion criteria will be excluded from this study:\n\n1. Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;\n2. Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture;\n3. Have had prior reconstructive surgery or fixation in the wrist."}, 'identificationModule': {'nctId': 'NCT03856450', 'briefTitle': 'Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study', 'orgStudyIdInfo': {'id': '124.02-2018-GES-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control-arm group', 'description': 'The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment.', 'interventionNames': ['Device: DTS', 'Device: X-ray']}, {'type': 'EXPERIMENTAL', 'label': 'Test-arm group', 'description': 'The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received.', 'interventionNames': ['Device: DTS', 'Device: X-ray', 'Device: MRI or CT']}], 'interventions': [{'name': 'DTS', 'type': 'DEVICE', 'otherNames': ['Digital Tomosynthesis (DTS)'], 'description': 'Subjects undergo wrist imaging using DTS.', 'armGroupLabels': ['Control-arm group', 'Test-arm group']}, {'name': 'X-ray', 'type': 'DEVICE', 'otherNames': ['X-ray imaging'], 'description': 'Subjects undergo wrist imaging using standard X-ray imaging.', 'armGroupLabels': ['Control-arm group', 'Test-arm group']}, {'name': 'MRI or CT', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)'], 'description': 'Subjects may undergo wrist imaging using MRI or CT.', 'armGroupLabels': ['Test-arm group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Steinberg, MD', 'role': 'CONTACT', 'email': 'David.Steinberg@uphs.upenn.edu', 'phone': '856-220-6985'}], 'facility': 'University of Pennsylvania Hospital - Department of Orthopaedic Surgery', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Mary Dooley', 'role': 'CONTACT', 'email': 'Mary.Dooley@uphs.upenn.edu', 'phone': '(215)-294-9650'}, {'name': 'David Steinberg, MD', 'role': 'CONTACT', 'email': 'David.Steinberg@uphs.upenn.edu', 'phone': '(856)-220-6985'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}