Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT01138592
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of hub (remote) observations with satellite (local) observations', 'timeFrame': '30 minutes', 'description': 'Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Auscultation of Heart and Lungs']}, 'descriptionModule': {'briefSummary': 'Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.\n\nSecondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Patients Hepatitis C Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects who are at least 18 years of age\n2. Subjects who are scheduled to undergo examination in a telemedicine setting\n3. Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.\n\nExclusion Criteria:\n\n1. Subjects who are unwilling to undergo additional examination in a telemedicine setting,\n2. Any subject requiring time-critical medical intervention.\n3. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT01138592', 'briefTitle': 'Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Pilot Study to Evaluate the Clinical Utility of 3M Littmann Scope-to-Scope Software for Real-time Assessment of Patients at Remote Clinic Locations by Centrally-located Medical Providers', 'orgStudyIdInfo': {'id': '05-003041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Care Patients', 'description': 'Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86004', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'facility': 'North Country Health Care', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}], 'overallOfficials': [{'name': 'Eric Henley, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Country Health Care, Flagstaff, AZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}