Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03041168
Status:
TERMINATED
Last Update Posted:
2021-11-11
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was stopped due to suspension of funding from CVR Global.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound', 'timeFrame': 'CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound'}], 'secondaryOutcomes': [{'measure': 'Difference between percent carotid artery stenosis measured by CSS and by carotid CTA', 'timeFrame': 'CSS reported percentage of carotid stenosis within 30 days of carotid CTA'}, {'measure': 'Difference between percent carotid artery stenosis measured by CSS and by carotid MRA', 'timeFrame': 'CSS reported percentage of carotid stenosis within 30 days of carotid MRA'}, {'measure': 'Difference between percent carotid artery stenosis measured by CSS and carotid angiogram', 'timeFrame': 'CSS reported percentage of carotid stenosis within 30 days of carotid angiogram'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Carotid Artery Disease']}, 'descriptionModule': {'briefSummary': 'The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.', 'detailedDescription': 'The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.\n\nSecondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients presenting to a Jefferson facility for carotid imaging studies. Subjects scheduled for carotid artery assessments will be identified prior to the day of study using radiology scheduling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over 18 referred for carotid duplex ultrasound.\n* Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries\n\nExclusion Criteria:\n\n* Previous history of carotid endarterectomy, carotid artery stent\n* Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)\n* Patients with prosthetic heart valve\n* Patients unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03041168', 'briefTitle': 'Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors', 'orgStudyIdInfo': {'id': '16G.774'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carotid Stenotic Scan', 'type': 'DEVICE', 'description': 'Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David J Whellan, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CVR Global, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}