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

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ClinicalTrials.gov Identifier: NCT03037827
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Medalp Private Surgery Clinic
Garantclinic
Information provided by (Responsible Party):
Denis Borsuk, 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.

Condition or disease Intervention/treatment Phase
Varicose Veins Procedure: Endovenous laser ablation (EVLA) Device: Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Procedure: Endovenous laser ablation (EVLA)
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

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

Active Comparator: 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
Procedure: Endovenous laser ablation (EVLA)
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

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

Active Comparator: 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
Procedure: Endovenous laser ablation (EVLA)
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain score [ Time Frame: day 1 ]
    Pain (numeric rating scale)

  2. Pain score [ Time Frame: day 7 ]
    Pain (numeric rating scale)


Other Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037827


Contacts
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Contact: Denis Borsuk, MD, PhD +79630777333 borsuk-angio@mail.ru

Locations
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Russian Federation
Clinic of Phlebology and Laser Surgery Recruiting
Chelyabinsk, Russian Federation
Contact: Denis Borsuk, MD, PhD    +79630777333    borsuk-angio@mail.ru   
Sub-Investigator: Roman Tauraginskiy, MD         
GarantClinic Recruiting
Moscow, Russian Federation
Contact: Ovsep Mandzhikian, MD, PhD    +79261076056    manjikyan@yahoo.com   
Sponsors and Collaborators
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Medalp Private Surgery Clinic
Garantclinic

Additional Information:
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Responsible Party: Denis Borsuk, Chief surgeon, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
ClinicalTrials.gov Identifier: NCT03037827     History of Changes
Other Study ID Numbers: A001
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia:
endovenous laser ablation
radial fiber
linear endovenous energy density
1470 nm
occlusion rate

Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases