Non-Invasive Testing Device for Anaemia

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.

NCT Number	NCT07361380
Lead Sponsor	University of Oxford
Conditions	Pregnancy
Enrollment	300 participants
Start Date	2024-10-28
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-27