Non-Invasive Testing Device for Anaemia

NCT07361380 | Recruiting

• 1 other identifier: 24/WS/0122
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pregnancy; Haemoglobin; Anaemia

Outcome Measures

Primary Outcomes (1)

• To compare Hb measured by VITA with Hb measured by blood sample analysis

  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 Outcomes (3)

• 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

  Baseline

• To train image processing software to detect biomarkers that are frequently used in clinical practice based on VITA images

  Baseline

• To predict long-term health outcomes from features in VITA images

  6 months post-partum

Study Arms (1)

Participants who are pregnant.

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: Women who are pregnant
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are pregnant.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX39DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be analysed for a) whole blood, plasma and serum lipid and inflammatory marker analysis and b) iron studies and c) analysis of biochemistry and metabolism and d) analysis of biomarkers associated with inflammation, angiogenesis and endothelial, liver, and kidney function.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Paul Leeson, PhD FRCP FESC

CONTACT

+44(0)1865 226845; paul.leeson@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 23, 2026
• Study Start: October 28, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)