Non-Invasive Testing Device for Anaemia (NITA)

University of Oxford

Status: Enrolling

Conditions: Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT07361380

24/WS/0122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Participants who are pregnant.