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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: EVLA 1940 nm; Procedure: EVLA 1470 nm

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas NEAUME, MD; Phone Number: +33 5 61 16 13 03; Email: nneaume@clinique-pasteur.com

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Contact: Nicolas NEAUME, MD; Phone Number: +33 5 61 16 13 01; Email: nneaume@clinique-pasteur.com
    • Principal Investigator: Nicolas NEAUME, MD
    • Sub-Investigator: Laurence Allouche, MD
    • Sub-Investigator: Fannie Forgues, MD
    • Sub-Investigator: Sarah Bruni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1940 nm; Endovenous laser at 1940 nm	Procedure: EVLA 1940 nm; Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
Active Comparator: 1470 nm; Endovenous laser at 1470 nm	Procedure: EVLA 1470 nm; Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical success	Closure of the target vein	At 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain	Visual Analogue Scale (0-100 mm); higher is worse	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events	Adverse events related to endovenous treatment	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Venous Clinical Severity	Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Symptoms	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (1)	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (2)	EuroQol-5 Dimension (EQ5D) Quality of life survey	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

Collaborators and Investigators

• Sponsor: Clinique Pasteur
• Investigators: Principal Investigator: Nicolas NEAUME, MD, Clinique Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Endovenous laser ablation (EVLA)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins
• Other Study ID Numbers: 2022-A01722-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No