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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2021-05-19

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.

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Detailed Description

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Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Endovenous laser ablation (EVLA) 5W

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

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation (EVLA)

Intervention Type PROCEDURE

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

Laser

Intervention Type DEVICE

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

Endovenous laser ablation (EVLA) 7W

One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation (EVLA)

Intervention Type PROCEDURE

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

Laser

Intervention Type DEVICE

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

Endovenous laser ablation (EVLA) 10W

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

Group Type ACTIVE_COMPARATOR

Endovenous laser ablation (EVLA)

Intervention Type PROCEDURE

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

Laser

Intervention Type DEVICE

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

Interventions

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Endovenous laser ablation (EVLA)

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

Intervention Type PROCEDURE

Laser

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No