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

Primary Purpose

Varicose Veins

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EVLA 1940 nm
EVLA 1470 nm
Sponsored by
Clinique Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring Endovenous laser ablation (EVLA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinique PasteurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1940 nm

1470 nm

Arm Description

Endovenous laser at 1940 nm

Endovenous laser at 1470 nm

Outcomes

Primary Outcome Measures

Anatomical success
Closure of the target vein

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2022
Last Updated
March 6, 2023
Sponsor
Clinique Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT05663359
Brief Title
Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)
Acronym
NEWWAVE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
February 2029 (Anticipated)
Study Completion Date
February 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Endovenous laser ablation (EVLA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1940 nm
Arm Type
Active Comparator
Arm Description
Endovenous laser at 1940 nm
Arm Title
1470 nm
Arm Type
Active Comparator
Arm Description
Endovenous laser at 1470 nm
Intervention Type
Procedure
Intervention Name(s)
EVLA 1940 nm
Intervention Description
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
Intervention Type
Procedure
Intervention Name(s)
EVLA 1470 nm
Intervention Description
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm
Primary Outcome Measure Information:
Title
Anatomical success
Description
Closure of the target vein
Time Frame
At 5 years
Secondary Outcome Measure Information:
Title
VAS Pain
Description
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
Title
Adverse Events
Description
Adverse events related to endovenous treatment
Time Frame
Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Title
Venous Clinical Severity
Description
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
Title
Symptoms
Description
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
Title
Patient quality of life (1)
Description
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
Title
Patient quality of life (2)
Description
EuroQol-5 Dimension (EQ5D) Quality of life survey
Time Frame
Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas NEAUME, MD
Phone
+33 5 61 16 13 03
Email
nneaume@clinique-pasteur.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas NEAUME, MD
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas NEAUME, MD
Phone
+33 5 61 16 13 01
Email
nneaume@clinique-pasteur.com
First Name & Middle Initial & Last Name & Degree
Nicolas NEAUME, MD
First Name & Middle Initial & Last Name & Degree
Laurence Allouche, MD
First Name & Middle Initial & Last Name & Degree
Fannie Forgues, MD
First Name & Middle Initial & Last Name & Degree
Yacine Oudrhiri, MD

12. IPD Sharing Statement

Learn more about this trial

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

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