RecruitingNAINTERVENTIONAL

LUMENS-1 EU EFS CIP

This study, called LUMENS-1, is looking at a new medical device called the LuSeed Aneurysm Embolization System. It's designed to treat a type of brain swelling called an 'unruptured intracranial aneurysm' (sometimes called a brain aneurysm or saccular aneurysm). These aneurysms haven't burst yet. The main goal of the study is to find out if this new device is safe and if it works as expected. It's a small study involving up to 30 people across different hospitals in Europe. Participants will be carefully chosen based on specific health guidelines to ensure their safety and the study's accuracy. The study will monitor participants to assess the device's early safety and how well it helps treat their aneurysm.

At a glance

Status

Recruiting

Phase

Sponsor

LuSeed Vascular LTD.

Enrolment target

Start

07 Oct 2024

Estimated completion

01 Jun 2027

Aneurysm Cerebral Bifurcation Unruptured Intracranial Aneurysm Saccular Aneurysm Brain Aneurysm

What is this study about?

Imagine a weak spot in the wall of a blood vessel in your brain, which bulges out like a tiny balloon. This bulge is called an 'aneurysm'. If it's 'unruptured', it means it hasn't burst or leaked yet. This study is testing a new device, called the LuSeed Aneurysm Embolization System, to help treat these unruptured brain aneurysms.

Doctors want to find out if this new device is a safe and effective way to fix these weak spots before they cause problems. They'll be watching closely to see how patients respond to the treatment and if the device works as it should. This type of research is important because it helps improve future treatments for people with similar health conditions.

The study involves a small group of patients, up to 30 people, across several hospitals in Europe. It's a careful step to ensure that new medical devices are thoroughly checked for safety and effectiveness before they can be used more widely. Your participation, if eligible, helps advance medical understanding and care.

Key takeaways

This study is testing a new device for unruptured brain aneurysms.
It aims to see if the device is safe and effective.
Only a small number of patients will be included.
Participation involves a procedure and follow-up checks.
You have the right to withdraw from the study at any time.
It's important to discuss any questions with your doctor.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 80 years old. You should have an unruptured brain aneurysm, which is a bulge in a blood vessel that hasn't burst or leaked. Your doctors would need to confirm that this new device is suitable for your specific aneurysm based on its size and location, and that you are healthy enough for this type of procedure.

There are also some reasons why you might not be able to join. For example, if your aneurysm has already ruptured, or if you have certain other serious health conditions like heart problems, kidney failure, or a recent stroke. Also, if you're pregnant, breastfeeding, or planning to get pregnant soon, you wouldn't be able to participate. You also shouldn't be allergic to materials in the device or certain medications like those used to prevent blood clots.

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 between 18 and 80 years old?
Do you have an unruptured brain aneurysm that your doctor says needs treatment?
Are you generally healthy enough for a keyhole procedure to treat your aneurysm?
Are you able and willing to attend follow-up appointments?
Are you not pregnant or breastfeeding, and not planning pregnancy soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part, doctors will perform a procedure to place the LuSeed device in your aneurysm. This is done by inserting a thin tube (catheter) into a blood vessel, usually in your groin, and guiding it up to your brain. You'll have regular check-ups and scans to make sure the device is working well and that you're recovering. The exact number of visits and tests will be explained in detail by the study team, but they will involve monitoring your health and the aneurysm over a period of time. You might also need to take certain medications, like blood thinners, and these would be carefully explained to you. The total duration of your participation in the study will depend on the follow-up schedule designed to assess the long-term safety and effectiveness of the device.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving a new treatment for your aneurysm that isn't widely available yet. However, like any medical procedure, there are potential risks, such as those associated with surgery or the device itself. These could include bleeding, infection, or other complications. The doctors will discuss all known and potential risks with you in detail. It's also very important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

University Hospital St. Ivan Rilski
Verified postcode
Sofia, Bulgaria· Recruiting
The University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
Sheba Medical Center
Verified postcode
Tel Litwinsky, Israel· Recruiting
UCK Katowice
Verified postcode
Katowice, Poland· Recruiting
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Verified postcode
Lodz, Poland· Recruiting
Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Verified postcode
Wroclaw, Poland· Not yet recruiting

Common questions

What is an unruptured brain aneurysm?

It's a weak spot in a blood vessel in your brain that swells outwards, but it hasn't burst or leaked yet.

What does the LuSeed device do?

It's a new device being tested to treat these unruptured brain aneurysms by helping to block them off and prevent them from growing or bursting.

Will I have surgery?

The device is placed using a procedure called 'endovascular embolization', where a thin tube is guided through your blood vessels, usually from your leg, up to the aneurysm in your brain.

How long will the study last for me?

The full duration of your participation, including follow-up visits and scans, will be explained by the study team. It's designed to monitor the device's performance over time.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Nitzan Hirsh

nitzan.h@luseed-vascular.com 972-545333200 Official trial record

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