Trenza Embolization Device for Intrasaccular Aneurysm Treatment
This study is examining a new medical device called Trenza, designed to treat brain aneurysms. It's a post-market study, meaning the device is already available, and researchers want to further assess its safety and how effectively it performs in real-world use. The study is for adults aged between 18 and 80 years old, who have a specific type of brain aneurysm located inside a blood vessel. It's being conducted across several hospitals in Europe and will follow patients to observe their progress. The main goal is to gather more information about the Trenza device to ensure it's a safe and effective treatment option.
At a glance
What is this study about?
Imagine a weak spot on a blood vessel in your brain that bulges out like a tiny balloon. This is called a brain aneurysm. If it bursts, it can be very dangerous. Doctors sometimes treat these by guiding tiny wires or other devices into the aneurysm to block it off and stop it from bursting or re-bleeding.
This particular study is looking at a new device called Trenza. It's already approved for use, but doctors want to keep a close eye on how well it works and if it's safe for people with a certain type of brain aneurysm, specifically those that are sac-shaped (like a small berry) and found inside a blood vessel. This type of study is important because it helps doctors and patients understand more about new treatments after they've been introduced.
The study will collect information from many hospitals across Europe. By doing this, researchers hope to build a clearer picture of the Trenza device's performance in a wider group of patients, adding to our understanding of how effective and safe it is for treating these specific brain aneurysms.
Key takeaways
- This study looks at a device called Trenza for treating brain aneurysms.
- It aims to check the safety and how well the device works.
- You need to be aged 18-80 with a specific type of brain aneurysm.
- The study involves a procedure and follow-up checks over time.
- It's a 'post-market' study to gather more real-world information on the device.
Who may be eligible?
To join this study, you would generally need to be an adult between 18 and 80 years old. You must have a single brain aneurysm that has not been treated before, and it needs to be the type that doctors can treat using a procedure where they go through your blood vessels. The aneurysm should be sac-shaped, meaning it looks like a small balloon or berry, and be a certain size – between 6mm and 12mm.
If your aneurysm has recently bled, you would need to be in a stable condition neurologically. You must also be willing to follow all the study procedures and attend follow-up appointments. Before anything starts, you will need to read and sign a consent form, showing you understand what the study involves and agree to take part.
There are also reasons you couldn't join. For example, if your aneurysm has been treated before, or if you have other serious brain conditions like a brain tumour, or other blood vessel problems in your brain. If doctors expect to treat your aneurysm in stages, or if you've had certain other treatments recently, you might not be able to participate.
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 a single brain aneurysm that hasn't been treated before?
- Is your aneurysm sac-shaped (like a berry)?
- Is your aneurysm between 6mm and 12mm in size?
- Are you willing to attend follow-up appointments and sign a consent form?
What does participation involve?
If you decide to take part, you'll first have a procedure where the Trenza device is used to treat your brain aneurysm. After the procedure, you'll need to attend regular follow-up appointments. These check-ups are important for the doctors to see how you are recovering and how the device is working. They might involve scans or other tests. The study will track your progress over time, and the doctors will explain the full schedule of visits and what each visit will involve.
Potential risks and benefits
Locations (18)
- Salzburg University HopsitalVerified postcodeSalzburg, Austria
- Helsinski University HospitalVerified postcodeHelsinki, Finland
- Turun yliopistollinen keskussairaalaVerified postcodeTurku, Finland
- Bordeaux HopsitalVerified postcodeBordeaux, France
- Brest HospitalVerified postcodeBrest, France
- HCL LyonVerified postcodeLyon, France
- Montpellier HospitalVerified postcodeMontpellier, France
- APHP BicêtreVerified postcodeParis, France
- Purpan HospitalVerified postcodeToulouse, France
- Universitätsklinikum Knappschaftskrankenhaus Bochum GmbHVerified postcodeBochum, Germany
- Asklepios Hospital Hamburg St. GeorgVerified postcodeHamburg, Germany
- Universitätsklinikum Schleswig-Holstein Campus LübeckVerified postcodeLübeck, Germany
Common questions
What is a brain aneurysm?
A brain aneurysm is a weak, bulging spot on a blood vessel in your brain, like a small balloon. If it bursts, it can cause serious problems.
What is the Trenza Embolization Device?
It's a special medical device used by doctors to treat certain types of brain aneurysms by blocking them off and preventing further issues.
Why is this study happening if the device is already approved?
This study helps doctors gather more information on how the Trenza device performs in a wider group of patients in real-world situations, further proving its safety and effectiveness.
Will I get paid to be in the study?
The study description doesn't mention payment for participation. This is something you should discuss with the study team.
How long will I be involved in the study?
The study will involve follow-up visits after your treatment. The exact duration will be explained by the study team if you are eligible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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