Varicose VeinsNEWWAVENCT05663359
Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)
A study testing EVLA 1940 nm and EVLA 1470 nm in people with Varicose Veins, run by Clinique Pasteur at 1 site in France.
Trial 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 : 1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- EVLA 1940 nm and EVLA 1470 nm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2023to Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Pasteur
Toulouse
Nicolas NEAUME, MD, +33 5 61 16 13 01, nneaume@clinique-pasteur.com
Nicolas NEAUME, MD
About this study
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.
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 :
Read more
- 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.
- Conditions
- Varicose Veins
- Being tested
- EVLA 1940 nm, EVLA 1470 nm
- Keywords
- Endovenous laser ablation (EVLA)
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLA 1940 nmProcedure or surgery
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
EVLA 1470 nmProcedure or surgery
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm
| Study group | Role | What they receive |
|---|---|---|
| 1940 nm | Active comparator | Endovenous laser at 1940 nm Receives: Procedure: EVLA 1940 nm |
| 1470 nm | Active comparator | Endovenous laser at 1470 nm Receives: Procedure: EVLA 1470 nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical success
Closure of the target vein
Measured: At 5 years
Secondary outcomes (6)
VAS Pain
Visual Analogue Scale (0-100 mm); higher is worse
Measured: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Adverse events related to endovenous treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start24 Feb 2023
- Primary completionFeb 2032 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas NEAUME, MD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663359
- Sponsor's protocol ID
- 2022-A01722-41
- Acronym
- NEWWAVE
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05663359
- Acronym / sponsor ID
- NEWWAVE / 2022-A01722-41
- Conditions
- Varicose Veins
- Keywords
- Endovenous laser ablation (EVLA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- Feb 2032 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1940 nm | Active comparator | Procedure: EVLA 1940 nmEndovenous laser at 1940 nm |
| 1470 nm | Active comparator | Procedure: EVLA 1470 nmEndovenous laser at 1470 nm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVLA 1940 nmTreatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm | Procedure or surgery | 1940 nm |
| EVLA 1470 nmTreatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm | Procedure or surgery | 1470 nm |
Primary outcome
Anatomical success
Time frame: At 5 years
Closure of the target vein
6 secondary outcomes
VAS Pain
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Venous Clinical Severity
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Symptoms
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (1)
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (2)
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas NEAUME, MD principal investigator
Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVLA 1940 nm and EVLA 1470 nm in people with Varicose Veins, run by Clinique Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas NEAUME, MD (+33 5 61 16 13 03, nneaume@clinique-pasteur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical success (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.