<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/NCT02200471</url>
  </required_header>
  <id_info>
    <org_study_id>SPN - 13 / 04 - 01</org_study_id>
    <nct_id>NCT02200471</nct_id>
  </id_info>
  <brief_title>Cosmetic Dermatology Study</brief_title>
  <official_title>Evaluation of VeinViewer in Cosmetic Dermatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christie Medical Holdings, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Christie Medical Holdings, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to understand the impact of VeinViewer technology during routine cosmetic and&#xD;
      dermatologic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was designed as an observational study to determine if VeinViewer technology&#xD;
      helped to improve the efficiency of certain dermatological procedures namely botox injections&#xD;
      and schlerotherapy for varicose veins. The device was used to identify veins but clinical&#xD;
      decisions were ultimately left the physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient perception of the use of the device</measure>
    <time_frame>Day 1</time_frame>
    <description>Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician perception of the use of the device</measure>
    <time_frame>Day 1</time_frame>
    <description>Physicians will complete a small questionnaire to understand what their perception of the use of the device to be (i.e, did the physician have a positive attitude towards the device while using it).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Detection of adverse events related to the standard of care procedure</measure>
    <time_frame>2nd day</time_frame>
    <description>VeinViewer may be used to detect adverse events related to the standard of care procedure (e.g., bruising).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Cosmetic Procedures</condition>
  <arm_group>
    <arm_group_label>VeinViewer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeinViewer</intervention_name>
    <arm_group_label>VeinViewer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and up&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Receiving cosmetic dermatological injection&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged younger than 18 years&#xD;
&#xD;
          -  Prior history of known light sensitivity&#xD;
&#xD;
          -  Other reasons as determined by investigator&#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>Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Laser Skin &amp; Vein Institute</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cosmetic dermatology</keyword>
  <keyword>near-infrared</keyword>
  <keyword>patient preference</keyword>
  <keyword>physician preference</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/NCT02200471
org study id: SPN - 13 / 04 - 01
nct id: NCT02200471
lead sponsor: 
has dmc: No
This study aims to understand the impact of VeinViewer technology during routine cosmetic and
      dermatologic procedures.
This study was designed as an observational study to determine if VeinViewer technology
      helped to improve the efficiency of certain dermatological procedures namely botox injections
      and schlerotherapy for varicose veins. The device was used to identify veins but clinical
      decisions were ultimately left the physician.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient perception of the use of the device
time frame: Day 1
description: Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?)
measure: Physician perception of the use of the device
time frame: Day 1
description: Physicians will complete a small questionnaire to understand what their perception of the use of the device to be (i.e, did the physician have a positive attitude towards the device while using it).
measure: Detection of adverse events related to the standard of care procedure
time frame: 2nd day
description: VeinViewer may be used to detect adverse events related to the standard of care procedure (e.g., bruising).
arm group label: VeinViewer
arm group type: Experimental
description: VeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires.
intervention type: Device
intervention name: VeinViewer
arm group label: VeinViewer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor