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Completed

NCT Number: NCT03037827

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

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovenous laser ablation (EVLA)

Procedure

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

laser

Device

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

Primary outcomes

  1. The number of participants with a fully obliterated target vein

    Time frame: 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 outcomes

  1. Pain score

    Time frame: day 1

    Pain (numeric rating scale)

  2. Pain score

    Time frame: day 7

    Pain (numeric rating scale)

Other outcomes

  1. Number of patients with adverse events

    Time frame: 3 month

  2. Paresthesia

    Time frame: 3 month

  3. Deep venous thrombosis

    Time frame: day 7

  4. Superficial venous thrombosis

    Time frame: day 7

Sponsors and collaborators

Lead sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Other

Collaborators

  • Garantclinic
  • Medalp Private Surgery Clinic

Registry information

Official study title

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

Acronym: SLEDGE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2017
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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