Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinique Pasteur
RECRUITING
Toulouse
Contact Information
Primary
Nicolas NEAUME, MD
nneaume@clinique-pasteur.com
+33 5 61 16 13 03
Time Frame
Start Date: 2023-02-24
Estimated Completion Date: 2031-02
Participants
Target number of participants: 280
Treatments
Active_comparator: 1940 nm
Endovenous laser at 1940 nm
Active_comparator: 1470 nm
Endovenous laser at 1470 nm
Related Therapeutic Areas
Sponsors
Leads: Clinique Pasteur

This content was sourced from clinicaltrials.gov