RecruitingNAINTERVENTIONAL

Radiation Free Study

This study, called the "Radiation Free Study," is looking at a new method to help doctors perform surgery for a serious condition called an Aortic Aneurysm. An aortic aneurysm is when the body's main blood vessel, the aorta, bulges out. The study aims to see if a special tool called LumiGuide can reduce the amount of X-ray (fluoroscopy) used during an operation called Fenestrated Endovascular Aortic Repair (FEVAR), compared to standard methods. Using less X-ray is generally safer for patients. Doctors from different hospitals in Europe and the US are taking part to make sure the results are useful for many people. If successful, this could mean safer procedures for patients needing this important surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Philips Clinical & Medical Affairs Global

Enrolment target

182

Start

03 Jul 2025

Estimated completion

30 Jun 2026

Aortic Aneurysm

What is this study about?

Imagine the body's main blood vessel, called the aorta, is like a garden hose. Sometimes, part of this hose can develop a weak spot and bulge out, which is called an aortic aneurysm. If it gets too big, it can be very dangerous.

Doctors can fix this with an operation called Fenestrated Endovascular Aortic Repair (FEVAR). During this surgery, doctors need to use X-rays, often called fluoroscopy, to help guide their instruments inside the body. This study wants to find out if a new guiding system, called LumiGuide, can help doctors use less X-ray during these operations. Using less X-ray means less radiation exposure for you, which is generally better for your health.

This study is being done in multiple hospitals in different countries, including the UK, Europe, and the US. This helps ensure that the results are reliable and can apply to many different patients and hospitals. The main goal is to show that using LumiGuide leads to less X-ray time compared to the usual way of doing things, hopefully making this vital surgery even safer.

Key takeaways

This study aims to make aneurysm surgery safer by reducing X-ray use.
It compares a new guiding system (LumiGuide) with the standard method.
Participation involves your planned FEVAR surgery, with no extra tests or visits.
Results could benefit future patients by improving surgical safety.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be part of this study, you would need to be having your first ever FEVAR operation to fix an aortic aneurysm. This surgery needs to involve the main arteries that go to your stomach, liver, and kidneys.

You must be at least 18 years old and able to understand and sign a consent form. Doctors would also need to believe you have a life expectancy of at least two more years to participate.

However, you wouldn't be able to join if you're having other types of blood vessel procedures at the same time, or if you've already had a FEVAR surgery. You also can't be in the study if you have certain conditions like Marfan's or Ehlers Danlos Syndrome, or if you have allergies to the dye used in X-rays. If you are pregnant or breastfeeding, or if you're already in another medical study that might affect this one, you also wouldn't be able to take part.

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 your very first FEVAR operation?
Are you 18 years old or older?
Is your FEVAR surgery involving the arteries to your stomach/kidneys?
Do you *not* have conditions like Marfan's Syndrome or Ehlers Danlos Syndrome?
Are you *not* pregnant or breastfeeding?
Are you *not* currently in another medical study that might conflict?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo your planned FEVAR surgery as usual. The only difference is that during your operation, you would be randomly assigned to have your doctor use either the new LumiGuide system or the standard X-ray guidance. You wouldn't know beforehand which method you will receive, and neither would your doctor. The study will mainly involve observing and recording the amount of X-ray time used during your surgery. There are no extra hospital visits or special medications required for this study beyond what your normal care would involve for this type of surgery. The total duration of your participation would be limited to the time of your procedure itself, with no long-term follow-up specifically for the study.

Potential risks and benefits

The potential benefit of participating is that the information gathered from your surgery could help improve FEVAR procedures for future patients, potentially leading to safer operations with less X-ray exposure. However, there's no direct benefit to you personally from using one guidance system over another, as both are established methods. The risks involved are generally those associated with the FEVAR surgery itself, regardless of the guidance method. Your care team will explain all the standard risks of the surgery. If you decide to join, you are free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (9)

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

University of Alabama
Verified postcode
Birmingham, United States· Not yet recruiting
University of Massachusetts
Verified postcode
Worcester, United States· Recruiting
University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
University of Texas Southwestern Medical Center
Verified postcode
Dallas, United States· Recruiting
UZ Gent
Verified postcode
Ghent, Belgium· Not yet recruiting
Rigshospitalet University Hospital
Verified postcode
Copenhagen, Denmark· Not yet recruiting
Hôpital Universitaire Pitié-Salpêtrière
Verified postcode
Paris, France· Not yet recruiting
UMC Maastricht
Verified postcode
Maastricht, Netherlands· Not yet recruiting
Guys & St Thomas
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is an Aortic Aneurysm?

It's a bulge in your body's main blood vessel, the aorta, which can be serious if it grows too large.

What is FEVAR surgery?

It's an operation to fix an aortic aneurysm, usually done by inserting special devices through small cuts.

What is the study trying to find out?

It's comparing two guidance methods during FEVAR surgery to see if a new system, LumiGuide, can reduce X-ray exposure.

Will I know if I'm getting the new system or the standard one?

No, you will be randomly assigned, and neither you nor your doctor will know which method is being used during your operation.

Are there extra appointments if I join?

No, there are no extra appointments. Your participation focuses on the procedure itself.

How to find out more

Bart Wessels

bart.wessels@philips.com bart.wessels@philips.com Official trial record

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