<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/NCT04486599</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/19/0516</org_study_id>
    <nct_id>NCT04486599</nct_id>
  </id_info>
  <brief_title>Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations</brief_title>
  <acronym>SCLERONAV</acronym>
  <official_title>Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation&#xD;
      in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility&#xD;
      will be defined in terms of the percentage of patients for whom the procedure is successful.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary interventional treatment of low flow vascular anomalies includes ultrasound guided&#xD;
      foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However,&#xD;
      procedures remain complicated to obtain the right trajectory in order to inject the foam at&#xD;
      the center of the abnormality. Electromagnetic navigation system tracks the operator's&#xD;
      needle, meaning the position and progression of the needle is visualized in 3D real time on&#xD;
      the ultrasound probe interface.&#xD;
&#xD;
      The present trial evaluate the feasibility of the electromagnetic navigation system during&#xD;
      the needle insertion and the improvement of needle placement accuracy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">May 12, 2022</completion_date>
  <primary_completion_date type="Actual">May 12, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients for whom the procedure is successful</measure>
    <time_frame>day 1</time_frame>
    <description>Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate the number of punctures required to achieve catheterization of the malformation.</measure>
    <time_frame>day 1</time_frame>
    <description>Number of percutaneous punctures needed to obtain vascular backflow.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the time to complete catheterization of the malformation</measure>
    <time_frame>day 1</time_frame>
    <description>Duration of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the undesirable effects associated with assisted electromagnetic navigation.</measure>
    <time_frame>day 1</time_frame>
    <description>Adverse effects of Electro-Magnetic Navigation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Venous Malformation</condition>
  <arm_group>
    <arm_group_label>Electromagnetic Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient have to low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI. Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic Navigation</intervention_name>
    <description>The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure.</description>
    <arm_group_label>Electromagnetic Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI&#xD;
&#xD;
          -  Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in&#xD;
             multidisciplinary staff meeting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with pacemakers or internal defibrillator&#xD;
&#xD;
          -  patients with ferromagnetic implanted material&#xD;
&#xD;
          -  patients who are wards of court or under guardianship&#xD;
&#xD;
          -  patients deprived of freedom by judicial or administrative decision&#xD;
&#xD;
          -  patients under legal protection&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wassim Mokaddem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Toulouse</city>
        <state>Occitanie</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Foam Sclerotherapy</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Electromagnetic Navigation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</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/NCT04486599
org study id: RC31/19/0516
nct id: NCT04486599
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation
      in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility
      will be defined in terms of the percentage of patients for whom the procedure is successful.
Primary interventional treatment of low flow vascular anomalies includes ultrasound guided
      foam sclerotherapy. Each procedure involves a percutaneous needle insertion. However,
      procedures remain complicated to obtain the right trajectory in order to inject the foam at
      the center of the abnormality. Electromagnetic navigation system tracks the operator's
      needle, meaning the position and progression of the needle is visualized in 3D real time on
      the ultrasound probe interface.

      The present trial evaluate the feasibility of the electromagnetic navigation system during
      the needle insertion and the improvement of needle placement accuracy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients for whom the procedure is successful
time frame: day 1
description: Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment.
measure: Estimate the number of punctures required to achieve catheterization of the malformation.
time frame: day 1
description: Number of percutaneous punctures needed to obtain vascular backflow.
measure: Estimate the time to complete catheterization of the malformation
time frame: day 1
description: Duration of the procedure.
measure: Estimate the undesirable effects associated with assisted electromagnetic navigation.
time frame: day 1
description: Adverse effects of Electro-Magnetic Navigation.
arm group label: Electromagnetic Navigation
arm group type: Experimental
description: The patient have to low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI. Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in multidisciplinary staff meeting
intervention type: Device
intervention name: Electromagnetic Navigation
description: The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure.
arm group label: Electromagnetic Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wassim Mokaddem, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
responsible party type: Sponsor
mesh term: Congenital Abnormalities