RecruitingOBSERVATIONAL

Non-Invasive Testing Device for Anaemia

This study is looking at a new, simple device called VITA. VITA uses high-resolution imaging technology to take detailed pictures of tiny blood vessels and cells in your ear. The goal is to see if VITA can quickly and accurately spot anaemia (low iron in the blood), especially iron deficiency anaemia, in pregnant women without having to take a blood sample. Currently, diagnosing anaemia usually means laboratory blood tests, which can be difficult to access or take time. If successful, VITA could make it much easier to diagnose and treat anaemia, helping pregnant women get the right support sooner. We want to compare VITA's results to standard blood tests to make sure it's reliable.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

300

Start

28 Oct 2024

Estimated completion

01 Oct 2026

Pregnancy

What is this study about?

Anaemia is a common problem, especially for pregnant women. It means you don't have enough healthy red blood cells or enough haemoglobin, which is a protein in red blood cells that carries oxygen around your body. Without enough oxygen, you can feel very tired, get headaches, and even lose hair. More seriously, untreated anaemia can lead to other health issues like chronic heart or kidney problems.

Currently, the best way to find out if you have anaemia is through a blood test in a lab. While these tests are accurate, they can be inconvenient. Sometimes it's difficult to get to a lab, and getting the results can take time. Also, existing quick tests for anaemia don't always tell doctors exactly why you have it, which is important for getting the right treatment.

That's why researchers have developed a new device called VITA (which stands for Vascular Imaging Tool for the Auricle). VITA is designed to be a portable and easy-to-use tool that can quickly detect anaemia without needing a blood sample. It works by taking detailed pictures of tiny blood vessels and cells in your ear. VITA is special because it can look at many individual cells, which current non-invasive devices can't do. The main aim of this study is to see how well VITA works compared to the traditional lab blood tests, helping us understand if it can accurately identify anaemia and specifically iron deficiency anaemia.

Key takeaways

A new device called VITA is being tested to detect anaemia in pregnant women.
VITA uses a non-invasive way to check for anaemia by imaging your ear.
This study aims to see how accurate VITA is compared to traditional blood tests.
Participating involves one visit for imaging with VITA and a standard blood test.
The goal is to develop a faster, easier way to diagnose anaemia, especially iron deficiency.
Your participation is voluntary and helps future medical advancements.

Who may be eligible?

To join this study, you need to be a pregnant woman between 16 and 50 years old. It's important that you are willing and able to understand the study and agree to take part.

There are a couple of reasons why you might not be able to join. If you have any ear piercings that can't be taken out temporarily, and these piercings would get in the way of the VITA device getting clear pictures of the blood vessels in your ear, then unfortunately you wouldn't be able to participate. Also, if your ear piercing would show up in the images taken by the device, you might not be eligible. This is because the device needs a clear view to work correctly.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant?
Are you between 16 and 50 years old?
Are you willing and able to give your consent to join the study?
Can you temporarily remove any ear piercings in the area that would be scanned?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve a short visit. During this visit, a researcher will use the VITA device to take pictures of your ear. This is a non-invasive process, meaning nothing will enter your body, and it shouldn't cause any discomfort. You will also have a standard blood test taken, which is usually done at a clinic or hospital anyway while you are pregnant. This blood test is important because it will be used to compare against the results from the VITA device to see how accurate VITA is. There are no medications involved in this study, and no long-term follow-up visits are typically needed beyond this initial assessment. The total duration of your active participation will be just for that one visit.

Potential risks and benefits

Taking part in this study could help advance medical understanding and potentially lead to better, quicker ways to diagnose anaemia in the future for pregnant women. You won't directly benefit from the VITA device itself during this study as it's still being tested, but your participation is valuable for future patients. The main risk involves the standard blood test, which might cause a little discomfort or bruising at the site where blood is taken, as with any blood draw. The VITA device itself is non-invasive and is not expected to have any risks. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your ongoing medical care.

Locations (1)

University of Oxford
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is anaemia?

Anaemia means you have too few healthy red blood cells or not enough haemoglobin, which carries oxygen in your blood. This can make you feel tired and weak.

What is the VITA device?

VITA is a new device that uses special pictures of your ear to quickly check if you have anaemia, without needing a blood sample.

Will VITA tell me if I have anaemia straight away?

This study is still testing VITA's accuracy, so results from the device won't be used for your immediate care. Your doctor will rely on standard blood tests for your diagnosis.

Do I need to do anything to prepare for the study?

The main thing is that any ear piercings that might block the device from taking clear pictures of your ear vessels need to be temporarily removed for the visit.

Is taking part safe?

Yes, the VITA device is non-invasive and completely safe. The only minor risks are typically associated with having a standard blood test, like a small bruise.

How to find out more

Paul Leeson, PhD FRCP FESC

paul.leeson@cardiov.ox.ac.uk +44(0)1865 226845 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.