Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT06136156
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2023-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video Vitals and Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate in beats per minute', 'timeFrame': '2 minutes'}, {'measure': 'Blood pressure (systolic/diastolic) in millimeters of mercury (mmHg)', 'timeFrame': '2 minutes'}, {'measure': 'Respiration rate in breaths per minute', 'timeFrame': '2 minutes'}, {'measure': 'Oxygen saturation in SpO2 percentage', 'timeFrame': '2 minutes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiometabolic Diseases']}, 'descriptionModule': {'briefSummary': 'The investigators are doing this research to study the ability of mobile devices to measure vital signs and biomarkers from video as compared to standard-of-care clinical office tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults greater than 18 years old may participate in this research study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to stay in a seated position for 30 minutes\n* Must be able to participate in a venous blood draw\n\nExclusion Criteria:\n\n* Condition that prevents prolonged seated position\n* Condition that restricts ability to provide venous blood sample'}, 'identificationModule': {'nctId': 'NCT06136156', 'briefTitle': 'Video Vitals and Biomarkers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maiv Health Inc.'}, 'officialTitle': 'Measuring Vital Signs and Biomarkers From Mobile Device Videos', 'orgStudyIdInfo': {'id': 'AX8'}}, 'contactsLocationsModule': {'locations': [{'zip': '78613', 'city': 'Cedar Park', 'state': 'Texas', 'country': 'United States', 'facility': 'ARCpoint Labs of Cedar Park', 'geoPoint': {'lat': 30.5052, 'lon': -97.82029}}], 'overallOfficials': [{'name': 'Sandro Luna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maiv Health Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maiv Health Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sandro Luna', 'investigatorAffiliation': 'Maiv Health Inc.'}}}}