<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/NCT02969005</url>
  </required_header>
  <id_info>
    <org_study_id>ChongqingMUCH</org_study_id>
    <nct_id>NCT02969005</nct_id>
  </id_info>
  <brief_title>Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure</brief_title>
  <official_title>Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Localization of small femur lesions for resection can be challenging and may be associated&#xD;
      with the need for significant fluoroscopic imaging and tissue dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was performed to evaluate the use of a radiopaque localizer grid along with&#xD;
      methylene blue staining for resection of small femur lesions in children, and to determine&#xD;
      this technique's effectiveness at reducing radiation exposure and tissue injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The times of C-arm fluoroscopy used</measure>
    <time_frame>intraoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incision length</measure>
    <time_frame>intraoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Bone Diseases</condition>
  <arm_group>
    <arm_group_label>surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>surgical treatment</intervention_name>
    <description>Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions</description>
    <arm_group_label>surgery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with lesions &lt;20.0 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with lesions &gt;20.0 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Guoxin Nan</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>radiopaque localizer grid</keyword>
  <keyword>methylene blue</keyword>
  <keyword>reduce radiation exposure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02969005
org study id: ChongqingMUCH
nct id: NCT02969005
lead sponsor: 
has dmc: No
Localization of small femur lesions for resection can be challenging and may be associated
      with the need for significant fluoroscopic imaging and tissue dissection.
This study was performed to evaluate the use of a radiopaque localizer grid along with
      methylene blue staining for resection of small femur lesions in children, and to determine
      this technique's effectiveness at reducing radiation exposure and tissue injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The times of C-arm fluoroscopy used
time frame: intraoperative
measure: incision length
time frame: intraoperative
arm group label: surgery group
arm group type: Experimental
description: The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected.
intervention type: Radiation
intervention name: surgical treatment
description: Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions
arm group label: surgery group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Chongqing Medical University
investigator full name: Guoxin Nan
investigator title: Director
mesh term: Bone Diseases
sharing ipd: No