<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/NCT01664572</url>
  </required_header>
  <id_info>
    <org_study_id>2012A00458-35</org_study_id>
    <nct_id>NCT01664572</nct_id>
  </id_info>
  <brief_title>Methodological Issues and Laser Speckle Contrast Imaging</brief_title>
  <acronym>METHODO-LSCI</acronym>
  <official_title>Methodological Issues of Laser Speckle Contrast Imaging for Studying Microcirculation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microcirculation, especially skin microcirculation, is a window towards systemic vascular&#xD;
      function in magnitude and underlying mechanisms. Different techniques have been developed to&#xD;
      assess the microcirculation. Among these techniques, laser technology is used to perform&#xD;
      non-invasive microvascular assessments. Although this technique is widely used, different&#xD;
      methodological issues remain. This study aims at defining the way to use lasers for clinical&#xD;
      use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Microvascular Function</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Residents of France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18years old&#xD;
&#xD;
          -  subject without any known cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Angers cedex 9</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>June 13, 2016</last_update_submitted>
  <last_update_submitted_qc>June 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laser Doppler flowmetry, skin blood flow</keyword>
  <!-- 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/NCT01664572
org study id: 2012A00458-35
nct id: NCT01664572
lead sponsor: 
has dmc: No
Microcirculation, especially skin microcirculation, is a window towards systemic vascular
      function in magnitude and underlying mechanisms. Different techniques have been developed to
      assess the microcirculation. Among these techniques, laser technology is used to perform
      non-invasive microvascular assessments. Although this technique is widely used, different
      methodological issues remain. This study aims at defining the way to use lasers for clinical
      use.
time perspective: Prospective
arm group label: Healthy subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor