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OpenTrials
Completed

NCT Number: NCT04573244

Hemoglobin Easy Measurement With Optical Artificial Intelligence

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.

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Key information

Conditions

Hemoglobin; Deficiency

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A patient aged 6 months to 18 years.
  • 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.
  • Parents or legal guardian provide informed written consent.

Exclusion criteria

  • Patient has subungual hematoma, nail bed lacerations or avulsion injuries on both hands.
  • Patient has total leukonychia.
  • Patient has nail polish applied on fingernails.
  • Patient has nailbed darkening or discoloration due to medication.
  • Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

MYOR Ltd.

Industry

Registry information

Official study title

A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents

Acronym: HEMO-AI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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