NCT03037827

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Varicose Veins

Interventions

Type	Name	Description
PROCEDURE	Endovenous laser ablation (EVLA)	Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber
DEVICE	Laser	Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

Timeline

• Start date: 2017-01-30
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2017-01-31
• Last updated: 2021-05-20

Locations

2 sites across 1 country: Russia