RecruitingNAINTERVENTIONAL

Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)

This research study is looking at two types of laser treatment for varicose veins in the legs. Both treatments use a technique called Endovenous Laser Ablation (EVLA), but they use different laser wavelengths: 1940 nanometres (nm) and 1470 nanometres (nm). The main aim is to find out if increasing the laser wavelength from 1470nm to 1940nm makes the treatment more effective, reduces the risk of complications, or causes less pain. People taking part are those with varicose veins in their legs who are already suitable for laser treatment. After the laser procedure, patients will be checked regularly for five years to see how well the treatment worked, if there were any problems, and how it affected their quality of life. This helps researchers understand the best way to treat varicose veins.

At a glance

Status

Recruiting

Phase

Sponsor

Clinique Pasteur

Enrolment target

280

Start

24 Feb 2023

Estimated completion

01 Feb 2032

Varicose Veins

What is this study about?

Varicose veins are common and can cause discomfort or other problems. One popular way to treat them is called Endovenous Laser Ablation (EVLA), which uses a laser inside the vein to close it off. This study is comparing two slightly different types of EVLA, using lasers with different *wavelengths*. Think of wavelength like a shade of light; even though both are lasers, they might interact with your body a little differently.

The researchers want to see if using a laser with a wavelength of 1940 nanometres (nm) is better than one with 1470 nm. They will be looking at a few important things: first, if the 1940 nm laser is equally good or better at treating the veins. Second, and crucially, they want to find out if the 1940 nm laser might lead to fewer complications or less pain for patients compared to the 1470 nm laser. This information is vital for doctors to provide the best and safest care for people with varicose veins.

Patients taking part in this study will be those who already need laser treatment for their leg varicose veins. After their laser procedure, they will have regular check-ups for five years. During these check-ups, doctors will assess how well the treatment worked, look for any potential side effects, and understand how the treatment has impacted their daily life. This long-term follow-up is important to truly understand the benefits and any long-term effects of each laser type.

Key takeaways

Compares two types of laser treatment for varicose veins.
Aims to find out if one laser causes fewer problems or less pain.
Participation involves having laser treatment and five years of follow-up.
Volunteers are people needing varicose vein laser treatment.
Helps doctors improve future varicose vein care.

Who may be eligible?

To join this study, you generally need to have varicose veins in your leg(s) that a doctor has decided can be treated with laser ablation. This typically means certain main veins in your leg, like the 'great saphenous vein' or 'small saphenous vein', aren't working properly.

There are also some specific health situations that would mean you can't take part. For example, if you have a serious illness that means you might not live for five years, or if you've had a blood clot (deep or superficial vein thrombosis) in the last six months. Also, if you have certain types of severe artery problems in your legs, or other complex vein issues, you wouldn't be able to join. Your doctor will carefully check all your health details to see if this study is suitable for you.

It's also important to be able to travel for follow-up appointments, understand the study information, and be able to give your clear agreement to take part. Pregnant or breastfeeding women cannot participate. If you are under guardianship or unable to give consent, you also wouldn't be eligible.

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.

Do you have varicose veins in your legs that your doctor thinks could be treated with a laser?
Are you generally in good health with a life expectancy of more than 5 years?
Have you NOT had a blood clot (deep or superficial) in your leg veins in the last 6 months?
Are you able to provide your full consent and travel for follow-up visits?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo one of the two laser treatments for your varicose veins, as determined by the study design. The procedure itself is similar to standard EVLA treatment. After your laser treatment, you will have regular medical check-ups over a period of five years. These appointments will involve your doctors checking your treated veins, discussing any symptoms you might have, and assessing your overall health and quality of life. You won't be taking any special medication related to the study beyond what your doctor would normally prescribe for varicose vein recovery. The total duration of your active involvement will be over these five years of follow-up.

Potential risks and benefits

There is a potential benefit that one of the laser treatments might prove to be more effective with fewer complications or less pain, which could improve your outcome. However, as with any medical procedure, there are potential risks, although EVLA is generally considered safe. These could include bruising, discomfort, or in rare cases, more serious issues that your doctor would discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Clinique Pasteur
Verified postcode
Toulouse, France· Recruiting

Common questions

What are varicose veins and why are they treated?

Varicose veins are swollen, twisted veins, usually in the legs, caused by faulty valves. They can cause pain, aching, or swelling, and occasionally lead to more serious problems, so treatment can relieve symptoms and improve health.

What is 'Endovenous Laser Ablation' (EVLA)?

EVLA is a common treatment for varicose veins. It involves inserting a thin laser fibre into the vein and using laser energy to heat and close off the faulty vein, redirecting blood flow to healthier veins.

What does '1940 nm vs 1470 nm' mean?

These numbers refer to the specific type or 'wavelength' of laser light used. The study is comparing two different laser wavelengths to see if one works better or causes fewer side effects.

Will I know which laser treatment I receive?

This is a research study, so you may not know which specific laser wavelength you receive. This helps ensure the results are fair and unbiased. Your doctor will explain how this works.

How often will I need to visit the hospital for follow-up?

You will have regular follow-up appointments over five years after your treatment. The exact schedule will be explained by the study team, but these are important to track your recovery and the long-term success of the treatment.

How to find out more

Nicolas NEAUME, MD

nneaume@clinique-pasteur.com +33 5 61 16 13 03 Official trial record

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