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

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: Endovenous laser ablation (EVLA); Device: Laser

• Registration Number: NCT03037827
• Lead Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-29
• Study Start: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-01-31
• Status Verified: 2021-05
• Primary Completion: 2021-05-19
• Study Completion: 2021-05-19
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovenous laser ablation (EVLA) 7W	Endovenous laser ablation (EVLA)	One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm
Endovenous laser ablation (EVLA) 5W	Laser	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
Endovenous laser ablation (EVLA) 7W	Laser	One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm
Endovenous laser ablation (EVLA) 10W	Endovenous laser ablation (EVLA)	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
Endovenous laser ablation (EVLA) 10W	Laser	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
Endovenous laser ablation (EVLA) 5W	Endovenous laser ablation (EVLA)	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain score	day 7	Pain (numeric rating scale)

Trial Locations

Locations (2)

Clinic of Phlebology and Laser Surgery; 🇷🇺 Chelyabinsk, Russian Federation

GarantClinic; 🇷🇺 Moscow, Russian Federation