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

Sponsor

Clinique Pasteur (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05663359

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 :

Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins	Procedure: EVLA 1940 nm Procedure: EVLA 1470 nm	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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.

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2029

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Anatomical success [At 5 years]
Closure of the target vein

Secondary Outcome Measures

VAS Pain [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
Adverse Events [Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
Adverse events related to endovenous treatment
Venous Clinical Severity [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
Symptoms [Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire
Patient quality of life (1) [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
Patient quality of life (2) [Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
EuroQol-5 Dimension (EQ5D) Quality of life survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Pasteur	Toulouse		France

Sponsors and Collaborators

Clinique Pasteur

Investigators

Principal Investigator: Nicolas NEAUME, MD, Clinique Pasteur

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas NEAUME, Principal Investigator, MD, Clinique Pasteur

ClinicalTrials.gov Identifier:

NCT05663359

Other Study ID Numbers:

2022-A01722-41

First Posted:

Dec 23, 2022

Last Update Posted:

Dec 23, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nicolas NEAUME, Principal Investigator, MD, Clinique Pasteur

Endovenous laser ablation (EVLA)

Additional relevant MeSH terms:

Varicose Veins

Study Results

No Results Posted as of Dec 23, 2022