Study on Treatment of Varicose Veins by Endovenous Laser... | NCT05663359

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

NCT05663359

Sponsor

Clinique Pasteur

Status

Recruiting

Last Update Posted

Mar 6, 2026Actual

Enrollment

280Estimated

Phase

Not Applicable

Conditions

Varicose Veins

Interventions

EVLA 1940 nm
EVLA 1470 nm

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2023Actual

Primary Completion Date

Feb 2032Estimated

Completion Date

Feb 2032Estimated

First Submitted Date

Dec 15, 2022

First Submission Date that Met QC Criteria

Dec 15, 2022

First Posted Date

Dec 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2026

Last Update Posted Date

Mar 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

280Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1940 nm	Active Comparator	Endovenous laser at 1940 nm	Procedure: EVLA 1940 nm
1470 nm	Active Comparator	Endovenous laser at 1470 nm	Procedure: EVLA 1470 nm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVLA 1940 nm	Procedure	Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm	1940 nm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases