RecruitingOBSERVATIONAL

A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product

This study is investigating a new tool called ISAR-M THYRO. After thyroid surgery, a small number of people can experience bleeding in the neck, which can be very serious and needs quick treatment. Currently, doctors mainly rely on symptoms or checks to spot this bleeding. This new device aims to continuously measure pressure in the neck for up to 48 hours after surgery. The idea is that a rise in pressure could be a sign of internal bleeding (a haematoma) before any symptoms appear. Detecting bleeding earlier could allow doctors to act faster, potentially preventing serious harm like brain damage, and making the surgery safer for patients.

At a glance

Status

Recruiting

Sponsor

ISAR-M GmbH

Enrolment target

1,470

Start

23 Oct 2023

Estimated completion

24 Nov 2024

Thyroid

What is this study about?

After you have surgery on your thyroid gland, which is in your neck, there's a small chance of bleeding happening afterwards. This bleeding is usually recognised within the first two days after your operation and can become serious very quickly. In some rare cases, it can even lead to very serious problems like brain damage or, tragically, death. Currently, doctors usually find this bleeding based on symptoms you might notice or by checking you regularly.

This study is looking at a new device called ISAR-M THYRO. The device is designed to measure the pressure in your neck continuously for about 36 to 48 hours after your thyroid surgery. The idea behind this is that if there's internal bleeding in your neck, it could cause the pressure to gradually increase. If this happens, the device would alert doctors to a potential problem much earlier than usual, even before you might feel any symptoms yourself.

By finding any bleeding earlier, doctors can take action more quickly. This could help prevent very serious complications and make the whole process safer for you. It might also help doctors make better decisions during any necessary follow-up procedures, potentially reducing further issues and improving your recovery.

Key takeaways

Tests a new device for detecting bleeding after thyroid surgery.
Aims for earlier detection of serious bleeding.
Could help prevent severe complications like brain damage.
Participation involves using the device for up to 48 hours post-surgery.
No new medications are given as part of the study.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. You must be having thyroid surgery, such as a total removal, partial removal, or a lobectomy, as part of your normal medical care, following standard guidelines.

Before you join, you will be asked to read and sign an informed consent form. This form explains the study fully and confirms you understand and agree to take part.

However, you won't be able to join the study if your surgery involves using a drain (a tube used to remove fluid from the body).

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 18 years old or older?
Are you having thyroid surgery?
Will you be able to sign a consent form?
Will your surgery *not* involve the use of drains?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the ISAR-M THYRO device will be used during and for up to 48 hours after your thyroid surgery to continuously measure the pressure in your neck. This is an observational study, which means the device will be used alongside your usual care, but no new medications will be given as part of the study itself. You will continue to receive the standard care and monitoring that you would normally get after your thyroid surgery. The total duration of your active participation with the device would be for up to 48 hours after your surgery.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of earlier detection of any serious bleeding after your thyroid surgery, which might lead to quicker treatment and better outcomes. As the device is attached during and after surgery, there might be minimal additional discomfort or a very small risk associated with its placement or presence, which would be explained in detail by your medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Krankenhaus Agatharied
Verified postcode
Hausham, Germany· Recruiting

Common questions

What is the ISAR-M THYRO device?

It's a new device being tested to measure pressure in your neck after thyroid surgery to detect bleeding early.

Why is early detection of bleeding important?

Finding bleeding early can help doctors act quickly to prevent serious complications like brain damage.

Does this study involve new medicines?

No, this study only involves using the ISAR-M THYRO device; no new medicines are given.

How long will the device be in place?

The device will be used for up to 48 hours after your thyroid surgery.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time, and it won't affect your medical care.

How to find out more

Olivia Fedunik-Brehm

olivia.fedunik-brehm@isar-m.com +491735667761 Official trial record

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