RecruitingOBSERVATIONAL

Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

This study, called SAPPHYRE, is looking at how well a device called the Polaris® 24 adjustable valve works for people with hydrocephalus. Hydrocephalus is a condition where too much fluid builds up in the brain. The valve helps drain this extra fluid away. Researchers are checking on its safety and how effectively it helps patients. They are looking at information from people who already have the valve and will also follow new patients for up to five years after they get it. This study aims to understand the real-world experience of using this valve to treat hydrocephalus in about 126 patients.

At a glance

Status

Recruiting

Sponsor

Sophysa

Enrolment target

126

Start

04 Jun 2021

Estimated completion

01 Jun 2033

Hydrocephalus

What is this study about?

This study is called SAPPHYRE, and it's looking into a medical device for people who have hydrocephalus. Hydrocephalus is a condition where there's too much fluid in and around the brain. This extra fluid can cause pressure and problems, so doctors often use a special tube system, called a shunt, with a valve to drain the fluid away to another part of the body where it can be safely absorbed.

The Polaris® 24 adjustable valve is one type of valve used in these shunt systems. The main goal of this study is to see how safe and effective this particular valve is for patients. Researchers want to understand how it works in real-life situations, making sure it helps people properly and doesn't cause any unexpected problems.

Doctors will be looking at information from about 126 patients. Some of these patients already have the Polaris® 24 valve, and others will receive it as part of their treatment. They will be followed for a long time – up to five years after their procedure – to get a complete picture of how the valve performs over time.

Key takeaways

This study evaluates the real-world safety and effectiveness of the Polaris® 24 valve.
It aims to improve understanding of this device for hydrocephalus treatment.
Participation involves sharing medical information from your regular care.
Patients are followed for up to five years after their valve procedure.
This is not a trial of a new medicine, but a check on an existing device.

Who may be eligible?

To be part of this study, you would need to have received the Polaris® 24 adjustable valve. This could be because you're getting a shunt for the first time, or if your old shunt's valve needed replacing, or if a different treatment for hydrocephalus didn't work.

Before joining, you'd also need to agree to be part of the study, which is called giving your 'informed consent'. This means you would be given all the information about the study and agree to take part voluntarily.

There are also some reasons why someone might not be able to join. For example, if you have an infection around your shunt or in another part of your body. Also, if you take certain blood-thinning medicines, have problems with bleeding, or have blood in the fluid around your brain, you wouldn't be able to join. If you have certain heart or lung problems and have a shunt that drains fluid directly to your heart, this study might not be right for you either.

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.

I have the Polaris® 24 adjustable valve (or am having one implanted).
I don't have an active infection.
I'm not on certain blood-thinning medicines or have bleeding issues.
I don't have certain serious heart or lung problems if I have a heart-draining shunt.
I am willing to give my permission to share my medical information for the study.

Answer every question to see your result.

What does participation involve?

If you are involved in this study, it's considered 'non-interventional.' This means you won't be given any new treatments or asked to do anything extra that you wouldn't normally do as part of your standard care for hydrocephalus. Instead, the doctors will simply be collecting information about how you are doing with your Polaris® 24 valve during your regular appointments and check-ups. They will follow your progress for up to five years after you've had the procedure to place or replace the valve.

Potential risks and benefits

The potential benefit of this study is that it helps doctors understand more about how well the Polaris® 24 valve works for people with hydrocephalus. This knowledge can improve care for future patients. Since this study uses information from your normal medical care, there aren't any extra risks from taking part, beyond the usual risks associated with living with hydrocephalus and having a shunt. You always have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (2)

La Timone Children's Hospital
Verified postcode
Marseille, France· Recruiting
La Pitié Salpétrière Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is hydrocephalus?

Hydrocephalus is a condition where too much fluid builds up in your brain, which can cause pressure and problems if not treated.

What is the Polaris® 24 adjustable valve?

It's a small device that's part of a shunt system. It helps drain extra fluid away from the brain to relieve pressure.

Will I get special treatment in this study?

No, you will receive your usual medical care. The study just collects information about how the valve works for you.

How long will I be followed in the study?

Doctors will follow your progress for up to five years after you have the valve implanted.

What if I change my mind about being in the study?

You are free to leave the study at any time, and it will not affect your medical care.

How to find out more

Océane Amiotte, Engineering Degree

oamiotte@sophysa.fr +33 381885382 Official trial record

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