<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03037827</url>
  </required_header>
  <id_info>
    <org_study_id>A001</org_study_id>
    <nct_id>NCT03037827</nct_id>
  </id_info>
  <brief_title>The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation</brief_title>
  <acronym>SLEDGE</acronym>
  <official_title>Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medalp Private Surgery Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Garantclinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter clinical randomized controlled trial, comparing of three different regimens of&#xD;
      endovenous laser ablation with equal linear endovenous energy density in patients with&#xD;
      insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED)&#xD;
      is the main value for standardization EVLA. From many studies, it is known the optimum value&#xD;
      of the LEED. However, the same LEED may be obtained by varying the ratio between the laser&#xD;
      power and the fiber pullback speed. Power decrease can allow to reduce the incidence of&#xD;
      adverse effects of endovenous laser ablation, but keep high efficiency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">May 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of participants with a fully obliterated target vein</measure>
    <time_frame>3 month</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>day 1</time_frame>
    <description>Pain (numeric rating scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>day 7</time_frame>
    <description>Pain (numeric rating scale)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Paresthesia</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Deep venous thrombosis</measure>
    <time_frame>day 7</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Superficial venous thrombosis</measure>
    <time_frame>day 7</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Varicose Veins</condition>
  <arm_group>
    <arm_group_label>Endovenous laser ablation (EVLA) 5W</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endovenous laser ablation (EVLA) 7W</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endovenous laser ablation (EVLA) 10W</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endovenous laser ablation (EVLA)</intervention_name>
    <description>Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber</description>
    <arm_group_label>Endovenous laser ablation (EVLA) 10W</arm_group_label>
    <arm_group_label>Endovenous laser ablation (EVLA) 5W</arm_group_label>
    <arm_group_label>Endovenous laser ablation (EVLA) 7W</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser</intervention_name>
    <description>Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm</description>
    <arm_group_label>Endovenous laser ablation (EVLA) 10W</arm_group_label>
    <arm_group_label>Endovenous laser ablation (EVLA) 5W</arm_group_label>
    <arm_group_label>Endovenous laser ablation (EVLA) 7W</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging,&#xD;
        reflux &gt; 0.5 sec No prior treatment of the insufficient GSV Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular&#xD;
        malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on&#xD;
        the thigh Immobility Allergy to lidocaine Arterial insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinic of Phlebology and Laser Surgery</name>
      <address>
        <city>Chelyabinsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GarantClinic</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://www.venousregistry.org/</url>
    <description>the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</investigator_affiliation>
    <investigator_full_name>Denis Borsuk</investigator_full_name>
    <investigator_title>Chief surgeon</investigator_title>
  </responsible_party>
  <keyword>endovenous laser ablation</keyword>
  <keyword>radial fiber</keyword>
  <keyword>linear endovenous energy density</keyword>
  <keyword>1470 nm</keyword>
  <keyword>occlusion rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037827
org study id: A001
nct id: NCT03037827
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The number of participants with a fully obliterated target vein
time frame: 3 month
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.
measure: Pain score
time frame: day 1
description: Pain (numeric rating scale)
measure: Pain score
time frame: day 7
description: Pain (numeric rating scale)
measure: Number of patients with adverse events
time frame: 3 month
measure: Paresthesia
time frame: 3 month
measure: Deep venous thrombosis
time frame: day 7
measure: Superficial venous thrombosis
time frame: day 7
arm group label: Endovenous laser ablation (EVLA) 5W
arm group type: Active Comparator
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 group label: Endovenous laser ablation (EVLA) 7W
arm group type: Active Comparator
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 group label: Endovenous laser ablation (EVLA) 10W
arm group type: Active Comparator
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: Endovenous laser ablation (EVLA)
description: Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber
arm group label: Endovenous laser ablation (EVLA) 10W
arm group label: Endovenous laser ablation (EVLA) 5W
arm group label: Endovenous laser ablation (EVLA) 7W
intervention type: Device
intervention name: Laser
description: Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
arm group label: Endovenous laser ablation (EVLA) 10W
arm group label: Endovenous laser ablation (EVLA) 5W
arm group label: Endovenous laser ablation (EVLA) 7W
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Russian Federation
url: http://www.venousregistry.org/
description: the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747
responsible party type: Principal Investigator
investigator affiliation: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
investigator full name: Denis Borsuk
investigator title: Chief surgeon
mesh term: Varicose Veins
sharing ipd: Yes
ipd 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)