<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/NCT02200458</url>
  </required_header>
  <id_info>
    <org_study_id>CP1019</org_study_id>
    <nct_id>NCT02200458</nct_id>
  </id_info>
  <brief_title>Near-infrared Software Performance Study</brief_title>
  <official_title>Near-Infrared Software Performance Study</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 will look at the performance capabilities of software for VeinViewer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will look at the performance capabilities of future software for VeinViewer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants for Whom Successful Visualization of Vasculature Was Achieved</measure>
    <time_frame>One day</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Vascular Access Complication</condition>
  <arm_group>
    <arm_group_label>VeinViewer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vascular imaging technology will be used to visualize peripheral vasculature.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeinViewer</intervention_name>
    <description>Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.</description>
    <arm_group_label>VeinViewer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be 18 years of age or older&#xD;
&#xD;
          2. Must be considered to be in overall good health by investigator&#xD;
&#xD;
          3. Must pass all prescreening questions&#xD;
&#xD;
          4. Must be able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for&#xD;
             cannulation.&#xD;
&#xD;
          2. IV cannulation in the arms or hands in the previous 4 weeks.&#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>
  <overall_official>
    <last_name>Gregory Schears, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christie Medical Holdings, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christie Medical Holdings, Inc.</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</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>
  <results_first_submitted>February 2, 2015</results_first_submitted>
  <results_first_submitted_qc>March 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 9, 2015</results_first_posted>
  <last_update_submitted>March 3, 2015</last_update_submitted>
  <last_update_submitted_qc>March 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VeinViewer</title>
          <description>Vascular imaging technology will be used to visualize peripheral vasculature.&#xD;
VeinViewer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VeinViewer</title>
          <description>Vascular imaging technology will be used to visualize peripheral vasculature.&#xD;
VeinViewer</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Average Age, Years</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.5" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>CM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.7" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.2" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick</title>
          <description>A numerical classification for human skin color: Type I (scores 0-6) Pale white, blond/red hair; blue eyes; freckles - Always burns/never tans. II (7-13) White/fair; blond/red hair; blue/green/hazel eyes - Usually burns/tans minimally. III (14-20) Cream white; fair with any hair/eye color; quite common - Sometimes mild burn/uniformly. IV (21-27) Olive to moderate brown; typical Mediterranean skin tone - Rarely burns/always tans well. V (28-34) Dark brown; South Asian skin types - Very rarely burns/tans very easily. VI (35+) Deeply pigmented dark brown to black - Never burns/tans very easily</description>
          <units>Points</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants for Whom Successful Visualization of Vasculature Was Achieved</title>
        <time_frame>One day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VeinViewer</title>
            <description>Vascular imaging technology will be used to visualize peripheral vasculature.&#xD;
VeinViewer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants for Whom Successful Visualization of Vasculature Was Achieved</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>VeinViewer</title>
          <description>Vascular imaging technology will be used to visualize peripheral vasculature.&#xD;
VeinViewer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Affairs Manager</name_or_title>
      <organization>Christie Medical Holdings, Inc.</organization>
      <phone>901-721-0330</phone>
      <email>christiemedinfo@christiedigital.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02200458
org study id: CP1019
nct id: NCT02200458
lead sponsor: 
has dmc: No
This study will look at the performance capabilities of software for VeinViewer.
This study will look at the performance capabilities of future software for VeinViewer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants for Whom Successful Visualization of Vasculature Was Achieved
time frame: One day
arm group label: VeinViewer
arm group type: Experimental
description: Vascular imaging technology will be used to visualize peripheral vasculature.
intervention type: Device
intervention name: VeinViewer
description: Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.
arm group label: VeinViewer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory Schears, MD
role: Principal Investigator
affiliation: Christie Medical Holdings, Inc.
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 