<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/NCT03810677</url>
  </required_header>
  <id_info>
    <org_study_id>ELVeS-01</org_study_id>
    <nct_id>NCT03810677</nct_id>
  </id_info>
  <brief_title>Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?</brief_title>
  <official_title>Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>be Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biolitec AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>be Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in&#xD;
      endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating&#xD;
      procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse&#xD;
      events and re-interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">March 8, 2021</completion_date>
  <primary_completion_date type="Actual">March 8, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Anatomic success</measure>
    <time_frame>at 1 month follow-up</time_frame>
    <description>defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomic success</measure>
    <time_frame>at 12 months follow-up</time_frame>
    <description>defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural characteristics</measure>
    <time_frame>at index-procedure</time_frame>
    <description>Details concerning the index-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scoring using the Visual Analog Scale (VAS)</measure>
    <time_frame>discharge</time_frame>
    <description>The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scoring using the Visual Analog Scale (VAS)</measure>
    <time_frame>at 1 week follow-up</time_frame>
    <description>The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)</measure>
    <time_frame>at 1 month follow-up</time_frame>
    <description>The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)</measure>
    <time_frame>at 12 months follow-up</time_frame>
    <description>The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative adverse events</measure>
    <time_frame>at 1 week follow-up</time_frame>
    <description>numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative adverse events</measure>
    <time_frame>at 1 month follow-up</time_frame>
    <description>numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative adverse events</measure>
    <time_frame>at 12 months follow-up</time_frame>
    <description>numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-interventions</measure>
    <time_frame>at 1 week follow-up</time_frame>
    <description>including reason for re-intervention and description of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-interventions</measure>
    <time_frame>at 1 month follow-up</time_frame>
    <description>including reason for re-intervention and description of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-interventions</measure>
    <time_frame>at 12 months follow-up</time_frame>
    <description>including reason for re-intervention and description of treatment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Varicose Veins</condition>
  <arm_group>
    <arm_group_label>Patients with varicose veins, eligible for EVLA</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELVeS® Radial® 2ring slim fiber</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>Patients with varicose veins, eligible for EVLA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation&#xD;
        (EVLA).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is at least 18 years old.&#xD;
&#xD;
          2. Patient must sign and date the informed consent form prior to treatment.&#xD;
&#xD;
          3. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥&#xD;
             C2).&#xD;
&#xD;
          4. Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation&#xD;
             of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein&#xD;
             (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence),&#xD;
             suitable for endovenous laser ablation (EVLA).&#xD;
&#xD;
          5. Maximum diameter of the to be treated veins is ≤ 14mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current deep vein thrombosis.&#xD;
&#xD;
          2. Acute superficial thrombosis.&#xD;
&#xD;
          3. Mean diameter of the to be treated veins &gt; 14mm.&#xD;
&#xD;
          4. Tortuous or very superficial veins considered unsuitable for laser treatment.&#xD;
&#xD;
          5. Recurrent varicose veins.&#xD;
&#xD;
          6. Pregnancy.&#xD;
&#xD;
          7. Coagulopathy or bleeding disorders.&#xD;
&#xD;
          8. Contraindications to the use of general or regional anesthesia.&#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>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <state>Antwerp</state>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <!-- 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/NCT03810677
org study id: ELVeS-01
nct id: NCT03810677
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in
      endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating
      procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse
      events and re-interventions.
observational model: Case-Only
time perspective: Prospective
measure: Anatomic success
time frame: at 1 month follow-up
description: defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
measure: Anatomic success
time frame: at 12 months follow-up
description: defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
measure: Procedural characteristics
time frame: at index-procedure
description: Details concerning the index-procedure
measure: Pain scoring using the Visual Analog Scale (VAS)
time frame: discharge
description: The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
measure: Pain scoring using the Visual Analog Scale (VAS)
time frame: at 1 week follow-up
description: The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
measure: Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
time frame: at 1 month follow-up
description: The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
measure: Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
time frame: at 12 months follow-up
description: The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
measure: Post-operative adverse events
time frame: at 1 week follow-up
description: numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
measure: Post-operative adverse events
time frame: at 1 month follow-up
description: numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
measure: Post-operative adverse events
time frame: at 12 months follow-up
description: numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
measure: Re-interventions
time frame: at 1 week follow-up
description: including reason for re-intervention and description of treatment
measure: Re-interventions
time frame: at 1 month follow-up
description: including reason for re-intervention and description of treatment
measure: Re-interventions
time frame: at 12 months follow-up
description: including reason for re-intervention and description of treatment
arm group label: Patients with varicose veins, eligible for EVLA
intervention type: Device
intervention name: ELVeS® Radial® 2ring slim fiber
description: Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
arm group label: Patients with varicose veins, eligible for EVLA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Varicose Veins