Comparing two laser wavelengths for treating varicose veins
Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.
This study is testing whether using two different laser wavelengths to treat varicose veins can help patients feel better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique Pasteur Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05663359 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different wavelengths (1940 nm and 1470 nm) used in Endovenous Laser Ablation (EVLA) for treating varicose veins in the lower limbs. The study will assess whether the higher wavelength improves treatment efficacy and reduces complications or pain compared to the lower wavelength. Participants will undergo laser ablation and will be monitored for five years to evaluate clinical outcomes, potential complications, and quality of life. The trial will involve patients with primary insufficiency of the great or small saphenous veins who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are patients with primary insufficiency of the great saphenous vein or small saphenous vein, with a vein diameter of 3 mm or greater.
Not a fit: Patients with serious underlying health conditions, recent vein thrombosis, or specific vascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with varicose veins, potentially enhancing efficacy and reducing complications.
How similar studies have performed: While there have been studies on EVLA, this specific comparison of wavelengths is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- Clinique Pasteur — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Nicolas NEAUME, MD — Clinique Pasteur
- Study coordinator: Nicolas NEAUME, MD
- Email: nneaume@clinique-pasteur.com
- Phone: +33 5 61 16 13 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.