Hemoglobin Easy Measurement With Optical Artificial Intelligence (HEMO-AI)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemoglobin; Deficiency

• Study Type: Observational
• Enrollment (Actual): 769

Contacts and Locations

• Study Contact: Name: Michael Brandwein; Phone Number: +972583325951; Email: michael@myorcare.com

Study Locations

• Israel
  • Afula, Israel
    • Emek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the Pediatric Department, Pediatric Emergency Department (PED) or Pediatric Hematology Unit (PHU) who have undergone a CBC

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify blood hemoglobin levels.	Evaluated using the hemoglobin portion of a conventional complete blood count (CBC)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6 months
To determine whether computational learning methods can be applied to fingernail images captured via a smartphone camera to quantify other elements of the CBC	Evaluated using the hemoglobin portion of a conventional complete blood count (CBC)	6 months

Collaborators and Investigators

• Sponsor: MYOR Ltd.
• Investigators: Principal Investigator: Gilad Moshe Chayen, MD, Emek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EMC 150-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No