Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03321851
Status:
UNKNOWN
Last Update Posted:
2018-03-06
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Vital sign results obtained by the device under study are not displayed on phone screen.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant tests two equivalent vital sign sensors (devices under test) mounted on two different smartphones, one after another to assess accuracy of the device compared to equivalent reference devices.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2017-10-12', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure accuracy to the reference device within the ranges specified by the ISO standard 81060-2', 'timeFrame': '4 months', 'description': 'For systolic and diastolic blood pressures, the mean error of determination of the individual paired determinations of the sphygmomanometer-under-test and the reference sphygmomanometer (Standby Baumanometer) for all participants shall not be greater than 8.0mmHg.'}, {'measure': 'Pulse Rate accuracy to the reference device within the ranges specified by the ISO 80601-2-61', 'timeFrame': '4 months', 'description': 'Pulse rate accuracy shall be stated as the root-mean-square (rms) difference between paired pulse rate data recorded with the pulse oximeter equipment and with the Nellcor N-PA reference device.'}, {'measure': 'Blood Oxygen accuracy to the reference device within the ranges specified by the ISO 80601-2-61.', 'timeFrame': '4 months', 'description': 'The SpO2 accuracy shall be stated as a root-mean-square (rms) difference of less than or equal to 4.0% SpO2 over the range of 70% to 100% SaO2'}, {'measure': 'Respiration rate accuracy', 'timeFrame': '4 months', 'description': "Respiration rate accuracy shall be stated as the root-mean-square (rms) difference between paired respiratory rate data with the Passport Respiration Rate Sensor PS-2133 reference method; target range +/- 10% of participant's respiratory rate"}, {'measure': 'Temperature accuracy to the reference device with the ranges specified by the ISO 80601-2-56 & ATSM 1965 Standard.', 'timeFrame': '4 months', 'description': "Temperature accuracy shall be stated as the root-mean-square (rms) difference between paired temperatures data recorded with the Exergen Temporal Scanner thermometer. LMD's target is a clinical bias \\<= 3.0°C and a clinical repeatability \\<= 3.0°C."}], 'secondaryOutcomes': [{'measure': 'No serious adverse device effects are reported.', 'timeFrame': '4 months', 'description': 'Zero serious adverse device effects are reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Accuracy of Vital Sign Pressure Sensor']}, 'descriptionModule': {'briefSummary': 'This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.', 'detailedDescription': "The five vital signs are blood pressure, pulse, respiration, SpO2, and temperature. The user tests two devices mounted on two smartphones.\n\n* Temperature: Each user will use the V-sensor mounted on a smartphone to obtain his/her temperature interfaced with a temperature specific 'app'. Before and after the the temperature is obtained using the V-Sensor, the temperature will be obtained using an equivalent thermometer.\n* Blood Pressure: Each user will test his/her blood pressure using the two sensors mounted on the two phones interfaced with a blood pressure specific 'app'. Before and after each measurement, a reference measurement using a mercury sphygmomanometer will be taken.\n* Pulse, Respiration, SpO2: Each user will test his/her pulse, respiration, and SpO2 using 2 V-sensors mounted on two separate smartphones interfaced with a Pulse, Respiration, and SpO2 'app'. Before and after each measurement, a reference measurement using equivalent reference devices will be taken."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent\n* 18 and 80 years old\n* no history or risk for developing lymphedema\n* no arteriovenous fistula in the right arm\n* no right limb amputation up to and including the right index finger\n* ability to obtain 3 readings from the device during the screening/training session.\n\nExclusion Criteria:\n\n* history of arrhythmia\n* arteriovenous fistula in the right arm\n* lymphedema or high risk for developing lymphedema in the right arm\n* inability to follow the procedures of the study\n* inability to hold the study device as instructed\n* inability to obtain 3 readings from the study device during the screening session\n* previous enrolment into the current study\n* enrolment of the Investigator or Sponsor, his/her family members, employees and other dependent persons.'}, 'identificationModule': {'nctId': 'NCT03321851', 'briefTitle': 'V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Léman Micro Devices SA'}, 'officialTitle': 'An Open Label, Interventional, Clinical Performance and Validation Study to Demonstrate the Clinical Accuracy of of the V-Sensor in the Healthy Adult Population; Single Site in Switzerland', 'orgStudyIdInfo': {'id': 'LMD-CT-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'V-Sensor Device User', 'description': "This diagnostic medical device is designed to detect the user's 5 vital signs. Each user tests two sensors, each sensor is mounted on a smartphone. Each vital sign is compared to an equivalent reference device obtained by the healthcare provider.", 'interventionNames': ['Device: V-sensor device user']}], 'interventions': [{'name': 'V-sensor device user', 'type': 'DEVICE', 'description': 'Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).', 'armGroupLabels': ['V-Sensor Device User']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kelly A McClary, RN', 'role': 'CONTACT', 'email': 'km@leman-micro.com', 'phone': '+41 (0)797764954'}, {'name': 'Chris J Elliott, PhD', 'role': 'CONTACT', 'email': 'cje@leman-micro.com', 'phone': '+41(0)791733306'}], 'overallOfficials': [{'name': 'Chris J Elliott, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Leman Micro-Device'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Léman Micro Devices SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}