Hemoglobin; DeficiencyHEMO-AINCT04573244
Hemoglobin Easy Measurement With Optical Artificial Intelligence
An observational study of Hemoglobin; Deficiency, run by MYOR Ltd. at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemoglobin; Deficiency
- How many people
- 823 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Dec 2020to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pediatric patients admitted to the Pediatric Department, Pediatric Emergency Department (PED) or Pediatric Hematology Unit (PHU) who have undergone a CBC
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemoglobin; Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start2 Dec 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemoglobin; DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- MYOR Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilad Moshe Chayen, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573244
- Sponsor's protocol ID
- EMC 150-20
- Acronym
- HEMO-AI
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2020
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39640961
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study to Explore the Utility of Using a Smartphone Camera to Monitor Blood Hemoglobin Levels in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04573244
- Acronym / sponsor ID
- HEMO-AI / EMC 150-20
- Conditions
- Hemoglobin; Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- MYOR Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients admitted to the Pediatric Department, Pediatric Emergency Department (PED) or Pediatric Hematology Unit (PHU) who have undergone a CBC
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 39640961Gordon 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.
- Individual participant dataSharing planned: No
Related trials for Hemoglobin; Deficiency
Recruiting
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Iron Deficiency Anemia Treatment
Not yet recruitingObservational study
Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety
Iron Deficiency, Latent Iron Deficiency
Not yet recruiting
Menstruation and Anemia Research: A Community Health Study
Anemia
Not yet recruitingObservational study
Impact of Iron Supplementation During Pregnancy
Anemia, Iron Deficiency Anaemia in Childbirth
Not yet recruiting
Iron-Rich Snack Intervention for Anemia in Adolescent Girls
Iron Deficiency Anemia (IDA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilad Moshe Chayen, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobin; Deficiency, run by MYOR Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.