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NCT Number: NCT05663359

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

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur

Toulouse, France

Location status: Recruiting

Location contact

Fannie Forgues, MD

SUB_INVESTIGATOR

Laurence Allouche, MD

SUB_INVESTIGATOR

Nicolas NEAUME, MD

CONTACT

[email protected]

+33 5 61 16 13 01

Nicolas NEAUME, MD

PRINCIPAL_INVESTIGATOR

Sarah Bruni, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent

Exclusion criteria

  • Patient with a current serious pathology and/or a life expectancy 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
  • Contraindication 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 informed consent or to answer the study questionnaires.
  • Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.

Treatment and study plan

EVLA 1940 nm

Procedure

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

EVLA 1470 nm

Procedure

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

Primary outcomes

  1. Anatomical success

    Time frame: At 5 years

    Closure of the target vein

Secondary outcomes

  1. VAS Pain

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

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

  2. Adverse Events

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

    Adverse events related to endovenous treatment

  3. Venous Clinical Severity

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

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

  4. Symptoms

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

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

  5. Patient quality of life (1)

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

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

  6. Patient quality of life (2)

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

    EuroQol-5 Dimension (EQ5D) Quality of life survey

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas NEAUME, MD

CONTACT

[email protected]

+33 5 61 16 13 03

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study title

Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.

Acronym: NEWWAVE

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Dec 23, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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