Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-02 @ 7:08 AM
Study NCT ID:
NCT02199457
Status:
WITHDRAWN
Last Update Posted:
2018-03-07
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Device development not completed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.', 'timeFrame': 'DAY 1', 'description': 'Accuracy of investigational device compared to the reference devices.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.', 'detailedDescription': 'The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT02199457', 'briefTitle': 'A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Léman Micro Devices SA'}, 'officialTitle': 'An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)', 'orgStudyIdInfo': {'id': 'LMD_CT_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SVSS and reference devices', 'description': 'Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor.', 'interventionNames': ['Device: SVSS and reference devices']}], 'interventions': [{'name': 'SVSS and reference devices', 'type': 'DEVICE', 'description': 'Blood pressure will be measured with standard mercury manometer', 'armGroupLabels': ['SVSS and reference devices']}, {'name': 'SVSS and reference devices', 'type': 'DEVICE', 'description': 'Body temperature taken with infrared thermometer', 'armGroupLabels': ['SVSS and reference devices']}, {'name': 'SVSS and reference devices', 'type': 'DEVICE', 'description': 'Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.', 'armGroupLabels': ['SVSS and reference devices']}, {'name': 'SVSS and reference devices', 'type': 'DEVICE', 'description': 'Measurement of respiration rate', 'armGroupLabels': ['SVSS and reference devices']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'EPFL', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Chris Elliott', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Léman Micro Devices SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}