Non-Invasive Testing Device for Anaemia

Recruiting now

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT07361380

Run by

University of Oxford

People needed

300

Starts

2024-10-28

Expected to finish

2026-10-01

Last updated by the study team

2026-01-27

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• University of Oxford — Oxford, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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