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Binah.ai Visual Vitals Application - Validation Study

Sponsor
Binah.ai LTD. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05539612
Collaborator
Clinimark, LLC (Other)
30
Enrollment
1
Location
2.5
Anticipated Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Binah.ai Visual Vitals Application - Validation Study
    Actual Study Start Date :
    Jul 18, 2022
    Actual Primary Completion Date :
    Aug 12, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Respiratory Rate accuracy validation [From admission to discharge, up to 2 hours]

      Respiratory Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).

    2. Pulse Rate accuracy validation [From admission to discharge, up to 2 hours]

      Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subject must have the ability to understand and provide written informed consent

    • Subject must be ≥18 years of age

    • Subject must be willing and able to comply with study procedures and duration

    Exclusion Criteria:

    • Subjects who refuse or are unable to provide to sign an informed written consent for study

    • Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening

    • Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region Of Interest (ROI) which would limit the ability to test ROI needed for the study.

    Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.)

    • Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)

    • Other known health condition, should be considered upon disclosure in health assessment form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinimark, LLC Louisville Colorado United States 80027

    Sponsors and Collaborators

    • Binah.ai LTD.
    • Clinimark, LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Binah.ai LTD.
    ClinicalTrials.gov Identifier:
    NCT05539612
    Other Study ID Numbers:
    • 2021-455
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 15, 2022