Hemoglobin Easy Measurement With Optical Artificial Intelligence

Completed

• Conditions: Hemoglobin; Deficiency

• Registration Number: NCT04573244
• Lead Sponsor: MYOR Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-27
• Study First Posted: 2020-10-05
• Study Start: 2020-12-02
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 823

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

Emek Medical Center; 🇮🇱 Afula, Israel