Hemoglobin Level MeasurementNCT04865224
Non-Invasive Estimation of Hemoglobin Levels in Blood Using Combined Deep Learning Methods
An observational study of Hemoglobin Level Measurement and Hemoglobin Level Estimation, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Hemoglobin is an important protein that gives the blood its red color and helps transport oxygen to organs. There are quite a lot of people in the world who need to have their hemoglobin levels checked regularly, especially anemia patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemoglobin Level Measurement, Hemoglobin Level Estimation
- What is being tested?
- hemoglobin estimation
- How many people
- 353 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 30 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People whose hemoglobin level has been measured in the clinic or laboratory.
Who may be able to join
- Individuals need to be healthy.
- Individuals should not have any active hand or nail disease.
- Individuals should know their hemoglobin level.
Who cannot join
- -In case of any condition that hides the natural nail color, such as henna, nail polish, protective or trauma-induced dents, bruises on the nails of individuals, it is removed from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Hemoglobin is an important protein that gives the blood its red color and helps transport oxygen to organs. There are quite a lot of people in the world who need to have their hemoglobin levels checked regularly, especially anemia patients. It is important to keep the hemoglobin levels in the blood of these individuals under control. For this, it is necessary to measure in frequent periods. A large group, from adults to children, needs to take these measurements. Most of these are invasive measurements made with blood that require devices and trained people. These painful methods are quite uncomfortable.
In this study, non-invasive hemoglobin level measurement was aimed with a combined DL model created by using nail images with age, height, weight, BMI, and gender information of the volunteers.
- Being tested
- hemoglobin estimation
- Keywords
- non-invasive, deep learning, hemoglobin level estimation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoglobin estimationDiagnostic test
In this method, in which different deep learning models are used together, the age range is intended to be as wide as possible to provide a quick solution with a high accuracy and low error values.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman analysis
Bland-Altman analysis was performed to make the results simpler and more understandable. This analysis is especially used in the simple and graphical expression of measurements in which two methods are compared.
Measured: 1 day
Estimation accuracy analysis
It is an analysis that compares the estimated hemoglobin values with the measured hemoglobin values.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start15 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemoglobin Level MeasurementStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Yılmaz, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865224
- Sponsor's protocol ID
- B17EUni-2020-34
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Estimation of Hemoglobin Levels in Blood Using Combined Deep Learning Methods
- ClinicalTrials.gov ID
- NCT04865224
- Acronym / sponsor ID
- B17EUni-2020-34
- Keywords
- non-invasive, deep learning, hemoglobin level estimation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Apr 2021 (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.
Hemoglobin is an important protein that gives the blood its red color and helps transport oxygen to organs. There are quite a lot of people in the world who need to have their hemoglobin levels checked regularly, especially anemia patients. It is important to keep the hemoglobin levels in the blood of these individuals under control. For this, it is necessary to measure in frequent periods. A large group, from adults to children, needs to take these measurements. Most of these are invasive measurements made with blood that require devices and trained people. These painful methods are quite uncomfortable.
In this study, non-invasive hemoglobin level measurement was aimed with a combined DL model created by using nail images with age, height, weight, BMI, and gender information of the volunteers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People whose hemoglobin level has been measured in the clinic or laboratory.
Key inclusion criteria (3 listed)
- Individuals need to be healthy.
- Individuals should not have any active hand or nail disease.
- Individuals should know their hemoglobin level.
Key exclusion criteria (1 listed)
- -In case of any condition that hides the natural nail color, such as henna, nail polish, protective or trauma-induced dents, bruises on the nails of individuals, it is removed from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemoglobin estimationIn this method, in which different deep learning models are used together, the age range is intended to be as wide as possible to provide a quick solution with a high accuracy and low error values. | Diagnostic test | – |
Primary outcome
Bland-Altman analysis
Time frame: 1 day
Bland-Altman analysis was performed to make the results simpler and more understandable. This analysis is especially used in the simple and graphical expression of measurements in which two methods are compared.
Estimation accuracy analysis
Time frame: 1 day
It is an analysis that compares the estimated hemoglobin values with the measured hemoglobin values.
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 29 Apr 2021.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
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Malnutrition, Child, Malnutrition, Infant
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Level Measurement and Hemoglobin Level Estimation, run by Karabuk University at 1 site in Turkey (Türkiye).
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 1 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 29 Apr 2021. 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 Turkey (Türkiye). 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?
Bland-Altman analysis (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.