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RecruitingNCT05663359NEWWAVEUpdated Mar 6, 2026

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

An interventional study of EVLA 1940 nm and EVLA 1470 nm in Varicose Veins, sponsored by Clinique Pasteur. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Clinique Pasteur · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs.

The main questions it aims to answers are :

  1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
  2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.

After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.

Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.

02

Conditions studied

  • Varicose Veins

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Keywords

  • Endovenous laser ablation (EVLA)
03

In context

Varicose Veins

226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.

This study's planned enrollment of 280 is above the median of 101 across 154 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)
  • Patient candidate for endothermic treatment of the lower limbs
  • CEAP: C2 - C6
  • Patient with a target vein diameter (GSV and/or SSV) >= 3 mm throughout the target vein segment
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having signed the

Exclusion criteria

Exclusion Criteria:

  • Patient with a current serious pathology and/or a of less than 5 years
  • Patient who has had a deep or superficial vein thrombosis in the previous 6 months
  • Obliterating arteriopathy of the lower limb concerned, with an IPS \< 0.8 or > 1.3
  • Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb
  • Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb
  • Suspicion of non-post-thrombotic iliac compression on echo-doppler
  • to the planned treatment technique
  • Patient whose geographical distance is not compatible with the follow-up of the study
  • Pregnant or breastfeeding women
  • Patient linguistically or psychologically unable to understand the information given, to give or to answer the study questionnaires.
  • Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Active comparator
    1940 nm

    Endovenous laser at 1940 nm

    Procedure: EVLA 1940 nm

  • Active comparator
    1470 nm

    Endovenous laser at 1470 nm

    Procedure: EVLA 1470 nm

Interventions

  • ProcedureEVLA 1940 nm

    Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm

  • ProcedureEVLA 1470 nm

    Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm

06

What researchers measure

Primary outcomes

  1. Anatomical success

    Closure of the target vein

    Time frame: At 5 years

Secondary outcomes

  1. VAS Pain

    Visual Analogue Scale (0-100 mm); higher is worse

    Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

  2. Adverse Events

    Adverse events related to endovenous treatment

    Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

  3. Venous Clinical Severity

    Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse

    Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

  4. Symptoms

    VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire

    Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

  5. Patient quality of life (1)

    VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire

    Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

  6. Patient quality of life (2)

    EuroQol-5 Dimension (EQ5D) Quality of life survey

    Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

07

Study locations

1 of 1 sites recruiting
  • Clinique Pasteur
    Toulouse, France
    Recruiting
    • Nicolas NEAUME, MD · Contactnneaume@clinique-pasteur.com · +33 5 61 16 13 01
    • Nicolas NEAUME, MD · Principal investigator
    • Laurence Allouche, MD · Sub investigator
    • Fannie Forgues, MD · Sub investigator
    • Sarah Bruni, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05663359
Lead sponsor
Clinique Pasteur
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Feb 24, 2023
Primary completion
Feb 2032 (estimated)
Completion
Feb 2032 (estimated)
Last update
Mar 6, 2026

Study contacts

Nicolas NEAUME, MD
Contact
nneaume@clinique-pasteur.com
+33 5 61 16 13 03
Nicolas NEAUME, MD
principal investigator · Clinique Pasteur

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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