RecruitingOBSERVATIONAL

Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study

This study is checking a device called a Celect Platinum Vena Cava Filter. This filter is placed in a large vein to catch blood clots and stop them from travelling to your lungs, which can be very dangerous. Researchers want to see how safe and effective this filter is for patients who've had it put in. They'll be watching patients over several years, up to five, to understand how the filter performs during its whole lifespan. This helps make sure the filter continues to be a good and safe option for people at risk of serious blood clots. The study is for people who have already had this filter implanted as part of their treatment.

At a glance

Status

Recruiting

Sponsor

Cook Research Incorporated

Enrolment target

Start

02 Jun 2025

Estimated completion

01 Dec 2030

Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism

What is this study about?

You might be hearing about this study because you or someone you know has a condition related to blood clots, like deep vein thrombosis (DVT) or pulmonary embolism (PE). These conditions mean you have blood clots, often in a deep vein, which can be very serious if they break off and travel to your lungs.

Doctors sometimes use a special device called a Celect Platinum Vena Cava Filter to help prevent these clots from reaching the lungs. It's like a tiny sieve placed inside a large vein called the vena cava. This study is all about watching how these filters work in real-life patients after they've been put in. It's not a new treatment being tested, but rather a check-up on an existing one.

The main goal is to make sure the filter continues to be safe and effective for patients over a long period, up to five years. By collecting information from many patients, doctors can confirm that the benefits of having the filter still outweigh any potential risks. They also want to see how the filter performs as time goes on while it's still inside the body.

Key takeaways

This study checks the Celect Platinum Vena Cava Filter you already have.
It helps doctors understand how the filter works long-term (up to 5 years).
There are no new treatments or extra appointments involved.
Your medical records provide the study information.
Participation helps improve care for future patients with blood clots.

Who may be eligible?

This study is for patients who have already had a Celect Platinum Vena Cava Filter put into their body as part of their medical treatment. Essentially, if your doctor has decided this filter is right for you and you've had it implanted, you might be suitable for this study.

You cannot join this study if you've already taken part in a different study called 'Cook MDR-2126'. The researchers also won't include you if you or your family (if you can't decide for yourself) don't want your health information to be collected and used for the study, or if you're not happy to sign a consent form.

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.

Have you had a Celect Platinum Vena Cava Filter implanted?
Have you *not* participated in the Cook MDR-2126 study before?
Are you willing for your health information to be collected for the study?
Are you happy to sign a consent form for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new treatments or medicines. Instead, the researchers will collect information from your medical records about the Celect Platinum Vena Cava Filter that you've already had implanted. This includes details about your health before and after the filter was put in, and how you are doing over time. This is an "observational" study, meaning doctors are observing your progress as they normally would and just collecting that data.

There are no extra hospital visits or special tests just for this study. The researchers will simply gather information from your routine check-ups and medical care related to your filter. They plan to follow patients for up to 5 years after the filter is implanted to understand its long-term performance. You won't have to take any extra medication.

Potential risks and benefits

Since this is an observational study using information from your routine care, there are no direct new medical risks involved with participating. The main benefit is that your information will help doctors understand more about the long-term safety and effectiveness of the Celect Platinum Vena Cava Filter, which can help improve care for future patients. You always have the right to change your mind and withdraw from the study at any time, even if you’ve already agreed to take part. This will not affect your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Hospital Universitari de Bellvitage
Verified postcode
Barcelona, Spain· Recruiting
Hospital Reina Sofia de Cordoba
Verified postcode
Córdoba, Spain· Recruiting
Parc Tauli
Verified postcode
Sabadell, Spain· Recruiting
Leeds Teaching Hospital NHS Trust
Verified postcode
Leeds, United Kingdom· Recruiting
Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom· Recruiting
Royal Liverpool Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting

Common questions

What is a Vena Cava Filter?

It's a small device placed in a large vein to catch blood clots before they can travel to your lungs and cause serious problems.

Will I get a new treatment in this study?

No, this study is about watching how a filter you've already had implanted works over time; you won't receive any new treatments.

How long will I be involved in the study?

Researchers plan to collect information about your filter for up to 5 years from when it was implanted.

Do I need extra doctor's appointments for this study?

No, this study will use information from your regular medical check-ups; you won't need any extra visits.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Sabina Andersen

sabina.hjorth@cookmedical.com +45 29 73 41 34 Official trial record

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