NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
This study, called NeuroNAV Study I, is looking into a new medical tool called the SmartGUIDE guidewire. It's designed to help doctors navigate inside blood vessels during procedures for unruptured brain aneurysms. An unruptured brain aneurysm is a bulge in a blood vessel in the brain that hasn't burst yet. The main goal is to check if using the SmartGUIDE guidewire is safe and works well. Researchers will compare how it performs against the standard tools doctors currently use, especially in terms of guiding instruments safely and successfully through the tiny blood vessels in the brain. This research aims to understand if this new technology could improve these important medical procedures.
At a glance
What is this study about?
Imagine your brain has a tiny balloon-like bulge on one of its blood vessels – this is called an unruptured brain aneurysm. Doctors sometimes need to guide very thin wires through your blood vessels to reach and treat this bulge, preventing it from bursting. This study is testing a brand-new type of guiding wire, called SmartGUIDE, to see if it makes these delicate procedures safer and more effective.
Current methods use standard guiding wires, but the SmartGUIDE is designed to be more flexible and easier for doctors to control from a distance. The researchers want to find out if this new, 'smart' wire helps doctors navigate through the brain's blood vessels just as well, or even better, than the current standard wires, while also being safe for patients.
By comparing the SmartGUIDE with existing wires, the study hopes to confirm that this new technology can be a reliable and beneficial tool for doctors, potentially improving how unruptured brain aneurysms are treated. It's a step towards finding better ways to help people with this condition.
Key takeaways
- This study tests a new 'smart' guidewire (SmartGUIDE) for unruptured brain aneurysms.
- It aims to confirm the SmartGUIDE is safe and effective compared to standard tools.
- Participation involves using the new guidewire during your planned aneurysm procedure.
- The goal is to improve how doctors navigate inside brain blood vessels.
- You must be 18+ and have an unruptured brain aneurysm treatable by this method.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old. You must also have an unruptured brain aneurysm that your doctor believes can be treated using a special procedure where tools are guided through your blood vessels. Before you can participate, you'll need to understand and sign a consent form.
There are certain reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you have certain health conditions like a bleeding disorder or a severe heart issue. Also, if you're allergic to Nickel or certain dyes used in medical scans, or if you have a condition that makes your blood vessels very fragile, you wouldn't be eligible.
Finally, if you're already taking part in another study that might affect the results of this one, you wouldn't be able to join. The doctors will carefully check all these points to make sure the study is right and safe for you.
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?
- Have you been diagnosed with an unruptured brain aneurysm?
- Are you able to have your aneurysm treated with a procedure involving guiding tools through blood vessels?
- Are you currently pregnant or breastfeeding?
- Do you have a known severe heart problem or bleeding disorder?
- Are you allergic to Nickel or certain dyes used in medical scans?
What does participation involve?
If you decide to participate, you would undergo the standard procedure for treating your unruptured brain aneurysm. During this procedure, instead of just using the usual guiding wire, your doctor would use the new SmartGUIDE guidewire. Apart from the guidewire itself, the treatment process would be very similar to what you would receive otherwise. There are no additional hospital visits or long-term check-ups specifically for the study beyond what your medical team would normally schedule for your aneurysm treatment. The primary focus is on observing the performance of the SmartGUIDE during your procedure.
Potential risks and benefits
Locations (1)
- Centre Hospitalier Universitaire - CHU LimogesVerified postcodeLimoges, France· Recruiting
Common questions
What is an unruptured cerebral aneurysm?
It's a weak spot in a blood vessel in your brain that bulges out like a tiny balloon but hasn't burst yet.
What is a guidewire?
It's a very thin, flexible wire that doctors use to help guide other medical instruments through your blood vessels during a procedure.
What is special about the SmartGUIDE guidewire?
It's a new type of guidewire that doctors can control remotely, aiming to make it easier and safer to navigate through tiny blood vessels in the brain.
Will I get special treatment in this study?
You will receive the standard treatment for your aneurysm, but with the new SmartGUIDE guidewire being used instead of the usual one during your procedure.
Can I stop participating in the study?
Yes, you can choose to leave the study at any point, and it won't affect the medical care you receive.
How to find out more
Guillaume Petit-Pierre, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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