<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/NCT02262494</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2013/XB-01</org_study_id>
    <secondary_id>2014-A00510-47</secondary_id>
    <nct_id>NCT02262494</nct_id>
  </id_info>
  <brief_title>Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography</brief_title>
  <acronym>EchoComp TVP</acronym>
  <official_title>Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of our study is to determine the diagnostic performance of an&#xD;
      ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by&#xD;
      experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients&#xD;
      with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed&#xD;
      by a vascular exploration expert.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The secondary objectives of this study are:&#xD;
&#xD;
        -  to compare the diagnostic performance of emergency compression ultrasonography performed&#xD;
           with and ultra-portable device (V-Scan®) with that of emergency compression&#xD;
           ultrasonography performed with a classic device&#xD;
&#xD;
        -  to compare the diagnostic performance of emergency compression ultrasonography between&#xD;
           patients suspected of having DVT arriving through the emergency department versus&#xD;
           similar patients sent in by their generalist&#xD;
&#xD;
        -  to compare the diagnostic performance of emergency compression ultrasonography among&#xD;
           patients with suspected DVT according to pre clinical probability testing based on the&#xD;
           Wells score (low, medium or high probability).&#xD;
&#xD;
      Currently, the use of ultra-portable ultrasound in this indication is not part of routine&#xD;
      care, and this study is therefore considered interventional in nature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 10, 2015</start_date>
  <completion_date type="Actual">October 19, 2016</completion_date>
  <primary_completion_date type="Actual">October 19, 2016</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of deep vein thrombosis by portable ultrasound: yes/no</measure>
    <time_frame>Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no</measure>
    <time_frame>Day 0</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of deep vein thrombosis by classic ultrasound: yes/no</measure>
    <time_frame>day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wells score</measure>
    <time_frame>Day 0</time_frame>
    <description>score ranging from 0 to 6</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Deep Vein Thrombosis</condition>
  <arm_group>
    <arm_group_label>Suspected first episode of DVT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital.&#xD;
Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>portable venous compression ultrasonography</intervention_name>
    <description>venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)</description>
    <arm_group_label>Suspected first episode of DVT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>venous compress ultrasonography</intervention_name>
    <description>venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)</description>
    <arm_group_label>Suspected first episode of DVT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Doppler ultrasound of the lower limbs</intervention_name>
    <description>Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)</description>
    <arm_group_label>Suspected first episode of DVT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given informed consent and signed consent&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  Patient consulting in the vascular exploration and medicine department for suspected&#xD;
             first episode of deep vein thrombosis&#xD;
&#xD;
          -  Ambulatory patient: defined as any outpatient coming in for a consult directly from&#xD;
             their place of residence or via the emergency department&#xD;
&#xD;
          -  Patient does not have a history of venous thromboembolism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient is participating in another study&#xD;
&#xD;
          -  The patient is in an exclusion period determined by a previous study&#xD;
&#xD;
          -  The patient is an adult under any kind of guardianship&#xD;
&#xD;
          -  The patient refuses to sign the consent&#xD;
&#xD;
          -  It is not possible to correctly inform the patient&#xD;
&#xD;
          -  Patient has a history of venous thromboembolism&#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>Xavier Bobbia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nîmes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU de Nîmes - Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes Cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</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>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Emergencies</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/NCT02262494
org study id: LOCAL/2013/XB-01
secondary id: 2014-A00510-47
nct id: NCT02262494
lead sponsor: 
has dmc: No
The main objective of our study is to determine the diagnostic performance of an
      ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by
      experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients
      with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed
      by a vascular exploration expert.
The secondary objectives of this study are:

        -  to compare the diagnostic performance of emergency compression ultrasonography performed
           with and ultra-portable device (V-Scan®) with that of emergency compression
           ultrasonography performed with a classic device

        -  to compare the diagnostic performance of emergency compression ultrasonography between
           patients suspected of having DVT arriving through the emergency department versus
           similar patients sent in by their generalist

        -  to compare the diagnostic performance of emergency compression ultrasonography among
           patients with suspected DVT according to pre clinical probability testing based on the
           Wells score (low, medium or high probability).

      Currently, the use of ultra-portable ultrasound in this indication is not part of routine
      care, and this study is therefore considered interventional in nature.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
time frame: Day 0
measure: Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
time frame: Day 0
measure: Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
time frame: day 0
measure: Wells score
time frame: Day 0
description: score ranging from 0 to 6
arm group label: Suspected first episode of DVT
arm group type: Other
description: The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital.
Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs
intervention type: Procedure
intervention name: portable venous compression ultrasonography
description: venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
arm group label: Suspected first episode of DVT
intervention type: Procedure
intervention name: venous compress ultrasonography
description: venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
arm group label: Suspected first episode of DVT
intervention type: Procedure
intervention name: Doppler ultrasound of the lower limbs
description: Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
arm group label: Suspected first episode of DVT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier Bobbia, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nîmes
facility: 
country: France
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Emergencies