RecruitingOBSERVATIONAL

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

This study, called BETTER-UAE, is looking at a treatment for women who have uncomfortable or painful growths in their womb called uterine fibroids. The treatment involves a procedure called Uterine Artery Embolization (UAE), where a special material called Bearing nsPVA is used to block the blood supply to the fibroids. This study will follow women who have this treatment in different hospitals to see how effective it is and if there are any problems or side effects. We will collect information on their health and how they are doing for up to 6 months after the procedure. It's an important way to make sure treatments are working well for patients.

At a glance

Status

Recruiting

Sponsor

Merit Medical Systems, Inc.

Enrolment target

100

Start

22 Aug 2024

Estimated completion

01 Dec 2026

Uterine Fibroid

What is this study about?

This study, known as BETTER-UAE, is designed to carefully watch how a treatment called Uterine Artery Embolization (UAE) works for women who have uterine fibroids. Uterine fibroids are common, non-cancerous growths that can appear in the womb (uterus). They can sometimes cause heavy periods, pain, or pressure. UAE is a procedure that aims to shrink these fibroids by blocking their blood supply using tiny particles. In this study, we are focusing on a specific type of these particles called Bearing nsPVA.

Doctors and researchers want to understand more about how well Bearing nsPVA works in real-world settings. They will be observing women who have this treatment in several hospitals across different locations. The main goal is to collect information on how safe the treatment is and how effective it is in helping women feel better. This kind of study helps us learn more about treatments after they've been approved for use, making sure they continue to meet patient needs.

The information collected will cover things like how patients recover, if their symptoms improve, and if they experience any side effects. This follow-up will happen over a period of 6 months. By gathering this detailed information, doctors can continue to improve care for women with uterine fibroids and ensure that the treatments available are as good as they can be.

Key takeaways

This study is observing a treatment for painful uterine fibroids.
It uses a method called Uterine Artery Embolization (UAE).
Doctors will follow patients for 6 months to check safety and how well it works.
The study focuses on a specific material called Bearing nsPVA used in UAE.
It helps doctors understand how the treatment performs in real-life situations.

Who may be eligible?

To be part of this study, you need to be an adult woman, at least 18 years old. You must have uterine fibroids that are causing you symptoms and that your doctor thinks can be treated successfully with this special procedure called embolization.

Before joining, you'll need to read and understand all the study details and then sign a consent form, which shows you agree to take part. This ensures you're fully informed about what the study involves.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant, or if you have an infection in your pelvis. You also cannot participate if you have any type of cancer in your pelvic area, such as cancer of the womb lining.

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 an adult woman, 18 years or older?
Do you have uterine fibroids that cause symptoms?
Has your doctor said that embolization (UAE) is a suitable treatment for you?
Are you NOT pregnant?
Do you NOT have an infection in your pelvis?
Do you NOT have cancer in your pelvic area?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will go through the standard Uterine Artery Embolization (UAE) procedure using the Bearing nsPVA particles as planned by your doctor for your fibroids. The study itself is mainly about observing your progress after the treatment. This means doctors will collect information during your regular follow-up appointments.

These appointments will include checks on your health, how your fibroid symptoms are changing, and if you have experienced any side effects. There might be questionnaires or discussions about your well-being. The study will continue to collect this information for 6 months after your embolization procedure. There are no new medications or extra procedures specifically for the study that are outside of your usual care plan. The total duration of your active involvement in the study's data collection will be up to 6 months.

Potential risks and benefits

Taking part in this study means you'll be receiving a treatment your doctor has already recommended for your fibroids. The potential benefits are the same as for anyone undergoing Uterine Artery Embolization – that your fibroids might shrink and your symptoms could improve. As with any medical procedure, there are potential risks associated with Uterine Artery Embolization, such as pain, infection, or other complications, which your doctor will discuss with you. This study is mainly observing patients who are already having the procedure, so it doesn't add new risks beyond the treatment itself. Remember, you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (4)

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

Astra Vascular/Astra Vein Treatment Center
Verified postcode
Brooklyn, United States· Active not recruiting
The Wesley Hospital
Verified postcode
Brisbane, Australia· Recruiting
Alfred Health
Verified postcode
Sydney, Australia· Recruiting
Royal Gwent Hospital (Aneurin Bevan UHB)
Verified postcode
Newport, United Kingdom· Recruiting

Common questions

What are uterine fibroids?

Uterine fibroids are common, harmless (non-cancerous) growths that develop in or on the wall of the womb (uterus). They can sometimes cause heavy bleeding or pain.

What is Uterine Artery Embolization (UAE)?

UAE is a procedure where doctors block the blood vessels that supply blood to the fibroids. This causes the fibroids to shrink and your symptoms to get better.

What is 'Bearing nsPVA'?

Bearing nsPVA is the specific type of tiny particle material used by doctors in this study to block the blood supply to the fibroids during the UAE procedure.

Will I get extra tests or treatments if I join the study?

No, this study mainly involves collecting information during your existing doctor's appointments and follow-ups. You won't have any extra treatments or tests specifically for the study that aren't part of your usual care.

How long will I be involved in the study?

The study will collect information about your health and recovery for about 6 months after you have your uterine fibroid embolization procedure.

How to find out more

Molly Ryan

molly.ryan@merit.com 314-620-7095 Official trial record

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