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

Primary Purpose

Varicose Veins

Status

Completed

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Endovenous laser ablation (EVLA)

Laser

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring endovenous laser ablation, radial fiber, linear endovenous energy density, 1470 nm, occlusion rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinic of Phlebology and Laser Surgery
GarantClinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Endovenous laser ablation (EVLA) 5W

Endovenous laser ablation (EVLA) 7W

Endovenous laser ablation (EVLA) 10W

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The number of participants with a fully obliterated target vein

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

Pain score

Pain (numeric rating scale)

Pain score

Pain (numeric rating scale)

Full Information

NCT ID

NCT03037827

First Posted

January 29, 2017

Last Updated

May 19, 2021

Sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Collaborators

Medalp Private Surgery Clinic, Garantclinic

1. Study Identification

Unique Protocol Identification Number

NCT03037827

Brief Title

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

Acronym

SLEDGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 30, 2017 (Actual)

Primary Completion Date

May 19, 2021 (Actual)

Study Completion Date

May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Collaborators

Medalp Private Surgery Clinic, Garantclinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Veins

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endovenous laser ablation (EVLA) 5W

Arm Type

Active Comparator

Arm Description

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

Arm Title

Endovenous laser ablation (EVLA) 7W

Arm Type

Active Comparator

Arm Description

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

Arm Title

Endovenous laser ablation (EVLA) 10W

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endovenous laser ablation (EVLA)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Laser

Intervention Description

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

Primary Outcome Measure Information:

Title

The number of participants with a fully obliterated target vein

Description

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.

Time Frame

3 month

Secondary Outcome Measure Information:

Title

Pain score

Description

Pain (numeric rating scale)

Time Frame

day 1

Title

Pain score

Description

Pain (numeric rating scale)

Time Frame

day 7

Other Pre-specified Outcome Measures:

Title

Number of patients with adverse events

Time Frame

3 month

Title

Paresthesia

Time Frame

3 month

Title

Deep venous thrombosis

Time Frame

day 7

Title

Superficial venous thrombosis

Time Frame

day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Clinic of Phlebology and Laser Surgery

City

Chelyabinsk

Country

Russian Federation

Facility Name

GarantClinic

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Access to the data will be available after completion of the study. To access the data will need to send a request to RRT CVD administrator. Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)

Links:

URL

http://www.venousregistry.org/

Description

the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747

Learn more about this trial

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

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