Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-02-22 @ 6:44 AM
Study NCT ID:
NCT02975050
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-29', 'releaseDate': '2022-10-11'}], 'estimatedResultsFirstSubmitDate': '2022-10-11'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate', 'timeFrame': 'Immediately', 'description': 'The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).'}, {'measure': 'Posture', 'timeFrame': 'Immediately', 'description': '90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position'}, {'measure': 'Activity', 'timeFrame': 'Immediately', 'description': 'μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.'}, {'measure': 'Heart Rate', 'timeFrame': 'Immediately'}, {'measure': 'ECG', 'timeFrame': 'Immediately'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Health Volunteer Validation Study']}, 'descriptionModule': {'briefSummary': 'This study has the following objective:\n\n• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.\n\nThe μ-Cor validation will be demonstrated at two body locations:\n\n1. Side location (below left armpit) for study arm 1, and\n2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.', 'detailedDescription': 'This study has the following objective:\n\n• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.\n\nThe μ-Cor validation will be demonstrated at two body locations:\n\n1. Side location (below left armpit) for study arm 1, and\n2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 21 years of age or older.\n* Subject is willing and able to sign the Informed Consent Form.\n* Subject is healthy, able and willing to complete all the preparation steps and study procedures.\n\nExclusion Criteria\n\n* Female subject with a known pregnancy or unsure about pregnancy status.\n* Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.\n* Subjects with skin breakdown in areas where device placement is required.\n* Subjects with chronic lung disease or asthma.\n* Subjects with a history of cardiovascular diseases.\n* Subjects who are diabetic.\n* Subjects living with kidney failure or dialysis.\n* Subjects with a history of liver failure.\n* Subjects with any known malignancy (i.e. cancer patients).\n* Subjects with implanted devices in the thoracic region'}, 'identificationModule': {'nctId': 'NCT02975050', 'acronym': 'ViVUS', 'briefTitle': 'Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)', 'orgStudyIdInfo': {'id': '2016-KM-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Side location', 'description': 'u-Cor device will be applied on side location', 'interventionNames': ['Other: Location']}, {'label': 'Front location', 'description': 'u-Cor device will be applied on front location', 'interventionNames': ['Other: Location']}], 'interventions': [{'name': 'Location', 'type': 'OTHER', 'armGroupLabels': ['Front location', 'Side location']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-11', 'type': 'RELEASE'}, {'date': '2023-08-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zoll Medical Corporation'}}}}