Active not recruitingOBSERVATIONAL

IMPEDE and IMPEDE-FX Embolization Plug Registry

This study, called IMPEDE and IMPEDE-FX, is collecting information about special medical devices known as embolization plugs. These plugs are like tiny stoppers that doctors use to block blood vessels outside of your heart and brain. This can be necessary for various health reasons, such as stopping unusual bleeding or preparing for surgery. The study aims to understand how well these IMPEDE and IMPEDE-FX plugs work, how safe they are, and if they help patients feel better. It involves observing patients who are already receiving these treatments as part of their care, rather than testing new, unproven methods. By gathering information from many patients, we hope to improve how these treatments are used in the future.

At a glance

Status

Active not recruiting

Sponsor

Shape Memory Medical, Inc.

Enrolment target

108

Start

09 Jul 2019

Estimated completion

01 Sep 2026

Peripheral Vascular Embolization

What is this study about?

This study is called the IMPEDE and IMPEDE-FX Embolization Plug Registry. It's a way for doctors to keep track of how well certain medical devices, called IMPEDE and IMPEDE-FX embolization plugs, work in people receiving treatment. These plugs are small devices used to block blood flow in specific blood vessels, usually outside of the heart or brain. Your body has a vast network of blood vessels, and sometimes, for different health reasons, doctors need to stop blood flow to a particular area.

Imagine a pipe with a leak, or a garden hose you want to turn off in a certain section – these plugs act a bit like a stopper. Doctors might use them to treat conditions where blood flow needs to be redirected, reduced, or stopped altogether. For example, they might be used to stop unusual bleeding, cut off blood supply to a non-cancerous growth, or prepare for surgery.

This study isn't testing a new medicine or treatment; it's simply a way to watch and learn about how these plugs are used in everyday medical practice. By collecting information from many people, the study helps medical professionals understand the benefits and any potential issues with these devices over time. This information is important for improving patient care and making sure these plugs are used in the best possible way.

Key takeaways

This study helps doctors learn more about specific devices called IMPEDE plugs.
It focuses on an existing treatment for blocking blood vessels outside the heart/brain.
Participation means doctors will observe your standard care and collect data.
You won't receive extra tests or different medications because of the study.
The aim is to improve care for future patients needing similar procedures.

Who may be eligible?

This study is looking for adults aged 18 or older. To take part, you must be a patient who your doctor thinks could benefit from a procedure called arterial or venous embolization. This is when doctors use special methods, like the IMPEDE plugs, to block a blood vessel in an area of your body other than your heart or brain.

There are a few reasons why someone might not be able to join the study. For example, you wouldn't be able to participate if you couldn't understand and sign the consent forms yourself, or if the treatment you're receiving isn't exactly what the study devices are designed for.

Also, if you are part of a group considered more vulnerable, such as prisoners, you wouldn't be included in this specific study. The main idea is to include adults who are clear candidates for embolization treatment with these specific plugs and can give their full permission to be part of the study.

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?
Has your doctor told you that you need a procedure to block a blood vessel (embolization) in your body?
Are you able to provide your written permission (consent) to be in a study?
Is your treatment planned using one of the IMPEDE or IMPEDE-FX plugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would mostly involve your doctors collecting information about your usual treatment. You wouldn't be asked to do anything extra or have any different tests than you would normally have as part of your care for a peripheral vascular embolization. The study will simply record what happens during your treatment with the IMPEDE or IMPEDE-FX plugs, and how you are doing afterwards. There won't be any additional specific visits just for the study, nor will you receive any different medication. The total length of your participation would depend on your treatment plan and how long your doctors typically follow up with patients after this type of procedure. The study itself is simply observing the standard care you'd already be receiving.

Potential risks and benefits

The potential benefit of participating in this type of study is that the information gathered from your treatment, along with many others, can help doctors better understand and improve the use of these embolization plugs for future patients. Because the study only observes your standard medical care, there are typically no additional risks directly linked to being in the study itself beyond the usual risks associated with your embolization procedure, which your doctor will discuss with you. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (10)

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

Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden
Verified postcode
Dresden, Germany
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein (Campus Kiel)
Verified postcode
Kiel, Germany
UNIVERSITÄTSKLINIKUM LEIPZIG AöR
Verified postcode
Leipzig, Germany
Klinikum München rechts der Isar
Verified postcode
München, Germany
Klinikum Nürnberg
Verified postcode
Nuremberg, Germany
Klinikum StuttGart
Verified postcode
Stuttgart, Germany
Uniklinikum Würzburg
Verified postcode
Würzburg, Germany
St George's Hospital (St George's University Hospitals NHS Foundation Trust)
Verified postcode
London, United Kingdom
St Mary's Hospital (Imperial College Healthcare NHS Trust)
Verified postcode
London, United Kingdom

Common questions

What is an embolization plug?

It's a small device doctors use to block a blood vessel. This can be needed for various health reasons, like stopping bleeding or changing blood flow.

Is this a new treatment being tested?

No, this study is observing how existing plugs (IMPEDE and IMPEDE-FX) work in people who are already receiving them as part of their standard care. It's not testing something brand new.

Who can join this study?

Adults aged 18 and over who are having a procedure to block a blood vessel outside the heart or brain using the IMPEDE or IMPEDE-FX plugs.

Will I get different treatment if I join?

No, you will receive the same standard treatment your doctor recommends. The study just collects information about how that treatment goes.

Can I stop being part of the study if I change my mind?

Yes, you can withdraw from the study at any time, and it will not affect your medical care.