Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 4:07 PM
Study NCT ID:
NCT01665820
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2012-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auscultate Obese Patients Using Electronic and Traditional Stethoscopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Most severe cardiac lesion identified by auscultation & echocardiography', 'timeFrame': '0-4 days'}], 'secondaryOutcomes': [{'measure': 'Secondary cardiac lesion identified by auscultation & echocardiography', 'timeFrame': '0 - 4 days'}, {'measure': 'Other heart sounds identified by auscultation & echocardiography', 'timeFrame': '0 - 4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chest', 'pathology'], 'conditions': ['Chest Pathology']}, 'descriptionModule': {'briefSummary': 'Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.', 'detailedDescription': 'Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been scheduled for an echocadiogram examination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater or equal than 18 years of age\n* Referred for an echocardiogram\n* obese, as defined as having a BMI greater than 30\n* volunteers to participate in study\n* agrees to provide copy of echocardiogram exam report\n\nExclusion Criteria:\n\n-Investigator believes subject should not be included or is unsuitable for inclusion'}, 'identificationModule': {'nctId': 'NCT01665820', 'briefTitle': 'Auscultate Obese Patients Using Electronic and Traditional Stethoscopes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue', 'orgStudyIdInfo': {'id': 'Study EM-05-012530'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Auscultate with mechanical stethoscope', 'description': 'Cardiologist \\& Medical Resident auscultate using mechanical stethoscope', 'interventionNames': ['Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)']}, {'label': 'Auscultate with electronic stethoscope', 'description': 'Cardiologist \\& Medical Resident auscultate using electronic stethoscope', 'interventionNames': ['Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)']}], 'interventions': [{'name': 'Auscultate with electronic or mechanical stethoscope (3M Littmann)', 'type': 'DEVICE', 'otherNames': ['3M Littmann 3200 Electronic Stethoscope', '3M Littman Cardiology III Mechanical Stethoscope'], 'armGroupLabels': ['Auscultate with electronic stethoscope', 'Auscultate with mechanical stethoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT-52490', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Lithuanian University of Health Sciences', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'overallOfficials': [{'name': 'Egle Kalinauskiene, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lithuanian University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}