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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03037827

Acronym

SLEDGE

Enrollment

203

Registered

2017-01-31

Start date

2017-01-30

Completion date

2021-05-19

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

endovenous laser ablation, radial fiber, linear endovenous energy density, 1470 nm, occlusion rate

Brief 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.

Interventions

DEVICELaser

Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

PROCEDUREEndovenous laser ablation (EVLA)

Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The number of participants with a fully obliterated target vein	3 month	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.

Secondary

Measure	Time frame	Description
Pain score	day 1	Pain (numeric rating scale)

Other

Measure	Time frame
Number of patients with adverse events	3 month
Paresthesia	3 month
Deep venous thrombosis	day 7
Superficial venous thrombosis	day 7

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026