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Video Vitals and Biomarkers

Sponsor
Maiv Health Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06136156
Collaborator
(none)
200
Enrollment
1
Location
11
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Measuring Vital Signs and Biomarkers From Mobile Device Videos
    Actual Study Start Date :
    Oct 31, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2024
    Anticipated Study Completion Date :
    Sep 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate in beats per minute [2 minutes]

    2. Blood pressure (systolic/diastolic) in millimeters of mercury (mmHg) [2 minutes]

    3. Respiration rate in breaths per minute [2 minutes]

    4. Oxygen saturation in SpO2 percentage [2 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Must be able to stay in a seated position for 30 minutes

    • Must be able to participate in a venous blood draw

    Exclusion Criteria:

    • Condition that prevents prolonged seated position

    • Condition that restricts ability to provide venous blood sample

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ARCpoint Labs of Cedar Park Cedar Park Texas United States 78613

    Sponsors and Collaborators

    • Maiv Health Inc.

    Investigators

    • Principal Investigator: Sandro Luna, MD, Maiv Health Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandro Luna, Principal Investigator, Maiv Health Inc.
    ClinicalTrials.gov Identifier:
    NCT06136156
    Other Study ID Numbers:
    • AX8
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No

    Study Results

    No Results Posted as of Nov 18, 2023