The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation

Study Overview
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Brief Summary
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A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.

Official Title
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Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: Endovenous laser ablation (EVLA)
* Device: Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec No prior treatment of the insufficient GSV Informed consent Exclusion Criteria: Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovenous laser ablation (EVLA) 5W<br>One of three different regimens of endovenous laser ablation, the fiber pullback speed 0.7 mm/s, laser power 5 W, LEED 71 J/cm | Procedure: Endovenous laser ablation (EVLA)<br>* Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber<br>Device: Laser<br>* Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm<br>|
| Active Comparator: Endovenous laser ablation (EVLA) 7W<br>One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm | Procedure: Endovenous laser ablation (EVLA)<br>* Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber<br>Device: Laser<br>* Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm<br>|
| Active Comparator: Endovenous laser ablation (EVLA) 10W<br>One of three different regimens of endovenous laser ablation, the fiber pullback speed 1.5 mm/s, laser power 10 W, LEED 67 J/cm | Procedure: Endovenous laser ablation (EVLA)<br>* Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber<br>Device: Laser<br>* Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with a fully obliterated target vein | An ultrasound investigation of the treated vein to find out is the treated vein is fully obliterated or not, and to find out is there any pathological reflux in the vein. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain (numeric rating scale) | day 1 | 
| Pain score | Pain (numeric rating scale) | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial fiber, 1470 nm, occlusion rate, endovenous laser ablation, linear endovenous energy density