NCT04865224

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

April 26, 2021

Last Update Submit

April 28, 2021

Conditions

Keywords

non-invasivedeep learninghemoglobin level estimation

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 day

  • Estimation accuracy analysis

    It is an analysis that compares the estimated hemoglobin values with the measured hemoglobin values.

    1 day

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People whose hemoglobin level has been measured in the clinic or laboratory.

You may qualify if:

  • Individuals need to be healthy.
  • Individuals should not have any active hand or nail disease.
  • Individuals should know their hemoglobin level.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78050, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. (Ph.D.)

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

July 15, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations