Hemoglobin Easy Measurement With Optical Artificial Intelligence

NCT04573244 | Completed

• 1 other identifier: EMC 150-20
• Study Type: observational
• Target: 823
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoglobin; Deficiency

Outcome Measures

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.

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

  6 months

Secondary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MYOR Ltd.: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

Related Publications (1)

• Gordon D, Hoffman J, Gamrasni K, Barlev Y, Levine A, Landau T, Shpiegel R, Lahad A, Koren A, Levin C, Naor O, Lee H, Liu X, Patel S, Chayen G, Brandwein M. Artificial intelligence-enabled non-invasive ubiquitous anemia screening: The HEMO-AI pilot study on pediatric population. Digit Health. 2024 Dec 5;10:20552076241297057. doi: 10.1177/20552076241297057. eCollection 2024 Jan-Dec.

  PMID: 39640961 DERIVED

Study Officials

• Gilad Moshe Chayen, MD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: December 2, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 23, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)