Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-28 @ 3:32 PM
Study NCT ID:
NCT01599195
Status:
TERMINATED
Last Update Posted:
2017-02-01
First Post:
2012-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive 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': 18}}, 'statusModule': {'whyStopped': 'Enrollment did not progress as anticipated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2012-05-02', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of bruit signal obtained from the amplified stethoscope(AudioDoc) to that found by conventional ultrasonography.', 'timeFrame': 'subjects will be followed for duration of hospital stay, typically four days.'}], 'secondaryOutcomes': [{'measure': 'To assess the frequency spectral differences obtained from the different recording modalities', 'timeFrame': 'duration of hospital stay, typically four days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['carotid stenosis', 'femoral artery ischemia', 'carotid bruit asymptomatic', 'carotid murmur'], 'conditions': ['Carotid Stenosis', 'Femoral Arterial Stenosis', 'Carotid Bruit Asymptomatic', 'Carotid Murmur']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test a new amplified stethoscope(AudioDoc) that can detect the presence of bruit by using an acoustic signal to represent the bruit. This pilot study will address two questions: is there a detectable difference in recorded sound signal of carotid and femoral bruit when compared to sound signals captured when there is no bruit present; is the use of a visual recorded signal more accurate in identifying carotid and femoral bruit when compared to traditional auscultation with a regular stethoscope and ultrasound.', 'detailedDescription': 'Recorded signals are stored on a laptop computer. The signals later undergo Fourier analysis are then compared to the findings on carotid ultrasoud as to degree of stenosis. Subjects with high grade stenosis in which no bruit was ascultated but in which carotid ultrasound data suggests a bruit may be present are studied for soft /inaudible bruits. When available, data will be correlated to CT/conventional angiographic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any person age 19 through 90 years who have been clinically determined to require evaluation of carotid or femoral arteries for suspected stenosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 19-90 years\n* having clinical ultrasound evaluation of carotid or femoral artery\n\nExclusion Criteria:\n\n* under age 19; over age 90 years'}, 'identificationModule': {'nctId': 'NCT01599195', 'briefTitle': 'Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'Use of Amplified Sound Signal to Identify Presence of Carotid and Femoral Stenosis', 'orgStudyIdInfo': {'id': 'HN 4209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adults', 'description': 'adults audiodoc use to evaluate for carotid or femoral bruit', 'interventionNames': ['Device: AudioDoc']}], 'interventions': [{'name': 'AudioDoc', 'type': 'DEVICE', 'description': 'AudioDoc will be used to identify the carotid and femoral bruit', 'armGroupLabels': ['adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Healthcare Network', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jonathan Dissin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein Healthcare Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jonathan Dissin, MD', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}