Non-Invasive Testing Device for Anaemia (NITA)

January 23, 2026 updated by: University of Oxford

Non-Invasive Testing of Blood Biomarkers in Pregnant Women

Anaemia (iron deficiency) arises from a reduction in the number of healthy red blood cells or the level of haemoglobin (Hb) (a protein inside red blood cells) necessary to effectively transport oxygen throughout the body. Anaemia is common among pregnant women. The gold standard for anaemia diagnosis still relies on laboratory blood tests, which come with limitations in terms of point-of-care capability, accessibility and quality. The investigators have developed a portable and user-friendly device capable of detecting anaemia rapidly and non-invasively and facilitating appropriate treatment by distinguishing anaemia due to iron deficiency from other causes. The device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small blood vessels within the human body. The objectives of this study are to assess VITA's performance of (haemoglobin (Hb)) testing and its ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Anaemia arises from a reduction in the number of healthy red blood cells or the level of haemoglobin necessary to transport oxygen effectively throughout the body. It is a significant global health concern, affecting 1.6 billion individuals worldwide and untreated anaemia can contribute to chronic heart failure and chronic kidney disease. Anaemia is common among pregnant women. Mild cases of anaemia often go unnoticed due to their nonspecific symptoms, such as fatigue, headaches, and hair loss. Furthermore, studying this disease can be difficult as, particularly in places without ready access to laboratory blood sample analysis as current point-of-care solutions are not able to distinguish between different types of anaemia and prescribe suitable treatments. The gold standard for anaemia diagnosis still relies on laboratory blood tests, which come with limitations in terms of point-of-care capability, accessibility, and biases related to poor standardisation of assays and low sample quality.

The investigators have developed a portable and user-friendly device capable of detecting anaemia rapidly and non-invasively and facilitating appropriate treatment by distinguishing anaemia due to iron deficiency from other causes. The device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small vessels within the human body. Unlike existing non-invasive devices that can only measure properties in bulk tissue samples, VITA can analyse characteristics of hundreds of individual cells, thereby facilitating rapid point-of-care testing for iron deficiency anaemia. VITA is a low-cost device, and its unique ability to measure these parameters without requiring consumables or trained operators makes it particularly well-suited for researching anaemia in a range of settings, including low- and middle-income countries.

This project is a proof-of-concept study to assess VITA's performance of Hb testing. Secondary objectives include testing VITA's ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests, identification of other frequently measured blood biomarkers, and identification of biomarkers for long-term health. This study is not collecting data for licensing of the device.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who are pregnant.

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Pregnant
  • Aged 16-50 years

Exclusion Criteria:

  • Ear piercings that cannot be temporarily removed that would prevent the ability of the VITA device to take images of the ear blood vessels.
  • Ear piercings that would be visible on the ear blood vessel images

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants who are pregnant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare Hb measured by VITA with Hb measured by blood sample analysis
Time Frame: Baseline
Agreement between the two measurements as calculated by systemic error (bias), and 95% limits of agreement as bias ±2 SD concentration of haemoglobin in the blood in g/dl of VITA and blood sample analysis
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the maximum accuracy of VITA in detecting iron deficiency anaemia as compared to diagnosis based on guidelines on full iron studies in blood sample analysis
Time Frame: Baseline
Accuracy of VITA algorithmic diagnosis (yes/no) compared to diagnosis (yes/no) based on haemoglobin, soluble transferrin receptor (sTfR), RDW (red cell distribution width), ferritin, serum iron, transferrin saturation (TSAT), mean corpuscular volume (MCV) and/or mean corpuscular haemoglobin concentration (MCHC)
Baseline
To train image processing software to detect biomarkers that are frequently used in clinical practice based on VITA images
Time Frame: Baseline

Correlation of VITA algorithmic metrics and blood sample analysis metrics of the following biomarkers:

  • Folate
  • Renal function
  • Electrolytes
  • Liver function
  • Calcium phosphate
  • Thyroid function
  • Full blood count
  • Glucose
  • Insulin
  • Lipids
  • HbA1C
Baseline
To predict long-term health outcomes from features in VITA images
Time Frame: 6 months post-partum

Medical records will be checked up to 6 months post-partum to check for the following indications:

  • Hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, HELLP)
  • Other pregnancy complications
  • Blood pressure
  • Post-partum medical complications
6 months post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24/WS/0122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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