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HEMO-AI: Hemoglobin Easy Measurement With Optical Artificial Intelligence

Sponsor
MYOR Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04573244
Collaborator
(none)
500
Enrollment
1
Location
24.9
Anticipated Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Blood hemoglobin levels are an extremely important measure for a large swath of medical procedures as they reflect the oxygen-carrying capacity of human blood. The gold standard measure for blood hemoglobin levels involve a venous blood draw followed by a laboratory-based complete blood count (CBC), a process which is both painful and time consuming. To date, various methodologies have been tested to either expediate the process or provide a non-invasive alternative. There remains a need to provide a quick, pain-free/non-invasive and accurate modality to measure blood hemoglobin levels. The objective of this study is to determine whether computer vision technologies can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents
    Actual Study Start Date :
    Dec 2, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels. [6 months]

      Evaluated using the hemoglobin portion of a conventional complete blood count (CBC)

    Secondary Outcome Measures

    1. To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to screen for anemia as defined by the WHO [6 months]

      Evaluated using the hemoglobin portion of a conventional complete blood count (CBC). Anemia cutoff for children aged 6 months to 6 years = 11 g/dL and for children aged 6-14 years = 12 g/dL.

    2. To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify other elements of the CBC [6 months]

      Evaluated using the hemoglobin portion of a conventional complete blood count (CBC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. A patient aged 6 months to 18 years.

    2. A patient who has undergone a venous blood draw for a CBC since being admitted to the PED no more than 6 hours prior to study enrollment.

    3. Parents or legal guardian provide informed written consent.

    Exclusion Criteria:

    1. Patient has subungual hematoma, nail bed lacerations or avulsion injuries on both hands.

    2. Patient has total leukonychia.

    3. Patient has nail polish applied on fingernails.

    4. Patient has nailbed darkening or discoloration due to medication.

    5. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emek Medical Center Afula Israel

    Sponsors and Collaborators

    • MYOR Ltd.

    Investigators

    • Principal Investigator: Gilad Moshe Chayen, MD, Emek Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MYOR Ltd.
    ClinicalTrials.gov Identifier:
    NCT04573244
    Other Study ID Numbers:
    • EMC 150-20
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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 Apr 7, 2022