Active not recruitingOBSERVATIONAL

GLYCAR Post Market Multicenter Study

This study is checking how a special patch, called GLYCAR Pericardial Patch, performs in people who are having surgery on their heart or major blood vessels. It's a 'real-world' study, meaning doctors will simply observe patients already getting this patch as part of their normal treatment. Up to 100 people across Europe, South Africa, and the USA will be included. The main goal is to see how well the patch works over time and if patients have any medical issues related to it after their surgery. It's not testing a new treatment, but rather gathering information on a patch that's already used.

At a glance

Status

Active not recruiting

Sponsor

GLYCAR SA (Pty) Ltd

Enrolment target

110

Start

09 Oct 2023

Estimated completion

01 Jun 2027

Congenital Premature Cardiac Closure Cardiac and Great Vessel Reconstruction and Repair Peripheral Vascular Reconstruction and Repair

What is this study about?

This study, called 'GLYCAR Post Market Multicenter Study,' is all about a medical patch named GLYCAR Pericardial Patch. When people need surgery on their heart or major blood vessels, sometimes doctors use patches to repair or rebuild parts of these important organs. The GLYCAR patch is one such device. This study aims to understand how well this patch works in real patients as part of their regular medical care.

Think of it like this: after a new car is sold, the company might check in with drivers to see how the car performs in everyday use. This study is similar. It's not a test to see if the patch itself works, but more of gathering information on how it performs in many different patients after it has been used in their surgery. Doctors will simply watch and record information about patients who have had the GLYCAR patch used during their operation. This helps doctors and the company make sure the patch is doing its job as expected and to understand any potential situations that might come up.

The study will involve up to 100 patients across various hospitals in Europe, South Africa, and the USA. All patients will be receiving the GLYCAR patch as part of their usual surgery. The main things the study wants to find out are how well the patch helps with the repair of the heart or blood vessel, and if any problems or side effects occur in the patients after their surgery. This information is important for improving patient care in the future.

Key takeaways

This study observes how a specific heart/blood vessel patch works in real patients.
It's for people already having surgery where the GLYCAR patch is used.
No extra treatments or appointments are needed if you participate.
The study helps doctors understand the patch's performance and safety.
Any risks are related to your surgery, not the study itself.
Participation is voluntary and won't affect your medical care.

Who may be eligible?

If you are having surgery on your heart or major blood vessels and your doctor decides to use the GLYCAR Pericardial Patch as part of your treatment, you might be able to be part of this study. The most important thing is that both you and your doctor agree that the patch is the best option for your care, following normal medical practice.

To join, you or your legal representative must also read and sign a consent form that explains the study in detail. This form will be approved by an ethical review board, which makes sure studies are safe and fair for patients.

There are no special reasons why someone would be excluded from this study, other than the general reasons why you might not be able to use the GLYCAR patch in the first place, as described by the manufacturer. If your doctor uses or tries to use the GLYCAR patch during your operation, and you've agreed to participate, then you'd generally be included.

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 having surgery on your heart or major blood vessels?
Has your doctor decided the GLYCAR Pericardial Patch is the right treatment for you?
Are you willing to sign a consent form approved by an ethics committee?
Do you understand that the patch is used as part of standard care, not as an experiment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it won't involve any extra appointments or special trips to the hospital just for the study. You will receive the GLYCAR patch as part of your planned heart or blood vessel surgery, just as you normally would. After your surgery, doctors will simply collect information from your medical records during your regular follow-up appointments. This means they'll be looking at things like your recovery and how the patch is performing based on the checks you'd already be having. You won't take any extra medication for the study, and the overall duration would typically follow your standard post-surgery care, likely over several months to a year, depending on your medical needs.

Potential risks and benefits

Because this study only observes how the GLYCAR patch performs when it's already being used as part of your standard medical care, there are no additional risks directly from being in the study itself. Any risks you experience would be those related to your surgery and the use of the GLYCAR patch, as decided by your medical team. The main potential benefit of taking part is that the information gathered from your experience can help doctors better understand how the GLYCAR patch works in many different patients, which could improve care for others in the future. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (4)

Marie Lannelongue Hospital
Verified postcode
Le Plessis-Robinson, France
Leipzig Heart Institute GmbH
Verified postcode
Leipzig, Germany
German Heart Center Munich (Deutsches Herzzentrum München)- Adult Section
Verified postcode
Munich, Germany
German Heart Center Munich (Deutsches Herzzentrum München)- Pediatric Section
Verified postcode
Munich, Germany

Common questions

What is the GLYCAR Pericardial Patch?

It's a special medical patch that doctors use during heart or major blood vessel surgery to help repair or rebuild damaged areas.

Am I receiving an experimental treatment?

No, if you're in this study, the GLYCAR patch is already a medical device used in standard care. The study is just observing its use.

Will I have extra doctor visits for this study?

No, you won't have any extra visits. Researchers will collect information during your normal post-surgery check-ups.

Can I decide not to be in the study if I change my mind?

Yes, you can choose to leave the study at any time, and it will not affect the medical care you receive.

Who is paying for this study?

The study, as a 'post-market' observation, is typically supported by the company that makes the GLYCAR patch, to gather real-world data.