Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
This study is looking at a new medical device called the nOCT Imaging System. This system helps doctors see inside blood vessels in the brain, especially when treating a condition called an intracranial aneurysm. An aneurysm is a bulge in a blood vessel. The nOCT system uses a tiny, flexible camera on a wire that goes into the blood vessel. It works with a computer and screen to show doctors detailed pictures. These pictures can help doctors understand the aneurysm better and check how well treatments, like coils or stents, are working. The main goal is to see if this new imaging system is safe and effective in providing clear pictures during and after aneurysm treatment.
At a glance
What is this study about?
This research study is looking at a new device called the nOCT Imaging System. Imagine your doctor needs to see inside one of the tiny blood vessels in your brain, especially if you have a condition called an intracranial aneurysm. An aneurysm is like a small balloon or bulge on a blood vessel wall.
Currently, doctors use different methods to treat these aneurysms, often by going inside the blood vessel with special tools (this is called an endovascular treatment). The nOCT system is designed to help doctors get a much clearer, up-close view of what's happening inside the vessel during these procedures. It works by having a very thin, flexible camera on a wire, called a probe, which is gently guided into the blood vessel. This probe is connected to a console, which is like a computer with a screen. The console sends a tiny, safe light down the probe, which then bounces back and creates detailed pictures of the inside of your blood vessel. These pictures show your doctor the blood vessel itself, the aneurysm, and any devices that might have been put in, like coils or stents, to treat the aneurysm.
The main aim of this study is to check if the nOCT system is safe to use and if it provides good quality images that help doctors assess the aneurysm and treatment effectively. This information could help improve how doctors treat brain aneurysms in the future and make sure treatments are working as they should.
Key takeaways
- This study uses a new camera (nOCT) to see inside brain blood vessels.
- It aims to help doctors treat brain aneurysms more effectively.
- The camera is tiny and used during your existing aneurysm procedure.
- It provides detailed pictures of the aneurysm and treatment devices.
- The study checks if the device is safe and provides useful information.
- Participation involves your planned treatment plus follow-up checks.
Who may be eligible?
To join this study, you would need to be between 18 and 75 years old and already planning to have treatment for a brain aneurysm, whether it's a new one or one that has been there for a while. You should also be generally healthy enough to participate in the study and understand what's involved. Your main blood vessel that will be treated needs to be a certain size, not too small or too large, for the device to a fit safely.
However, some things might mean you can't take part. For example, if you've recently had a stroke or mini-stroke, or if your blood's clotting ability is very low. Also, if your aneurysm is particularly complex or shaped in a way that makes using the device unsafe, you wouldn't be able to join. If you have other serious health problems that might make taking part risky, or if you're allergic to certain medications used in the procedure, you also wouldn't be suitable.
Ultimately, your doctor will carefully review all your health information to make sure that taking part in this study is safe and appropriate 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.
- Am I between 18 and 75 years old?
- Am I having treatment for a brain aneurysm soon?
- Is my main treatment blood vessel not too small or too large?
- Have I not had a stroke or mini-stroke in the last 30 days?
- Do I not have certain serious health conditions that would make me unsuitable?
- Am I willing to come for follow-up appointments?
What does participation involve?
If you decide to take part in this study, the nOCT imaging procedure will happen during your planned treatment for your brain aneurysm. This means no extra surgical procedures specifically for the study. The nOCT probe will be guided into your blood vessel through the same small tubes (catheters) that doctors already use for your aneurysm treatment.
After your treatment, your doctor will review the images taken by the nOCT system. There will likely be follow-up appointments, similar to what you would have for your aneurysm treatment anyway, to see how you are recovering and how the treatment worked. During these follow-up visits, doctors may use the nOCT system again to check on the aneurysm and any devices that were placed. The exact number and timing of these follow-up visits will be explained to you by the study team, and you'll know the total duration of your participation.
Potential risks and benefits
Locations (8)
- Baptist Health Research InstituteVerified postcodeJacksonville, United States· Recruiting
- Tampa General HospitalVerified postcodeTampa, United States· Recruiting
- Advocate Aurora Research InstituteVerified postcodePark Ridge, United States· Recruiting
- Tufts Medical Center, Inc.Verified postcodeBoston, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Not yet recruiting
- University at Buffalo Neurosurgery (UBNS)Verified postcodeBuffalo, United States· Not yet recruiting
- ENERI - Clinica La Sagrada Familia Av del LibertadorVerified postcodeBuenos Aires, Argentina· Not yet recruiting
- St. Michael's HospitalVerified postcodeToronto, Canada· Not yet recruiting
Common questions
What is an intracranial aneurysm?
It's a bulge or weak spot in the wall of a blood vessel in your brain, similar to a small balloon.
What does a 'probe' do?
It's a tiny, flexible camera on a wire that goes inside your blood vessel to take pictures.
Will this add extra procedures to my treatment?
No, the nOCT system is used during your already planned aneurysm treatment, so there are no extra operations.
Is the light used in the system harmful?
No, the system uses a very low-power laser light, which is considered safe for imaging.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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