<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/NCT02224287</url>
  </required_header>
  <id_info>
    <org_study_id>P00003145</org_study_id>
    <nct_id>NCT02224287</nct_id>
  </id_info>
  <brief_title>Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control</brief_title>
  <official_title>Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized trial to study the effect of assigning the control of the&#xD;
      fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist.&#xD;
      Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose&#xD;
      parameters (cumulative absorbed dose and dose area product). From exposure data, entrance&#xD;
      skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in&#xD;
      this study will be total fluoroscopy time for the procedure. A secondary outcome will be the&#xD;
      ESD. The investigators will further analyze the contribution of clinical predictors (e.g.&#xD;
      stone size/location) and procedural predictors on fluoroscopy times and ESD.&#xD;
&#xD;
      It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating&#xD;
      surgeon is controlling the activation of the x-ray beam.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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 primary outcome in this study will be total fluoroscopy time for the procedure.</measure>
    <time_frame>1-5 hours</time_frame>
    <description>The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.</measure>
    <time_frame>1-5 hours</time_frame>
    <description>The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Urolithiasis</condition>
  <condition>Kidney Stones</condition>
  <arm_group>
    <arm_group_label>Fluoroscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Technologist control of fluoroscopy Surgeon control of fluoroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Technologist control of fluoroscopy</intervention_name>
    <description>Technologist control of fluoroscopy</description>
    <arm_group_label>Fluoroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgeon control of fluoroscopy</intervention_name>
    <description>Surgeon control of fluoroscopy</description>
    <arm_group_label>Fluoroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing ureteroscopy for urolithiasis&#xD;
&#xD;
          -  5 years to 25 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Less than 5 years old or older than 25 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caleb Nelson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Caleb Nelson</investigator_full_name>
    <investigator_title>Caleb Nelson MD, MPH</investigator_title>
  </responsible_party>
  <keyword>Urolithiasis</keyword>
  <keyword>Kidney Stones</keyword>
  <keyword>Ureteroscopy</keyword>
  <keyword>Fluoroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</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/NCT02224287
org study id: P00003145
nct id: NCT02224287
lead sponsor: 
has dmc: Yes
This is a prospective randomized trial to study the effect of assigning the control of the
      fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist.
      Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose
      parameters (cumulative absorbed dose and dose area product). From exposure data, entrance
      skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in
      this study will be total fluoroscopy time for the procedure. A secondary outcome will be the
      ESD. The investigators will further analyze the contribution of clinical predictors (e.g.
      stone size/location) and procedural predictors on fluoroscopy times and ESD.

      It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating
      surgeon is controlling the activation of the x-ray beam.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome in this study will be total fluoroscopy time for the procedure.
time frame: 1-5 hours
description: The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
measure: A secondary outcome will be the entrance skin dose (mGy). We will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and entrance skin dose.
time frame: 1-5 hours
description: The average duration of a ureteroscopy is 1-5 hours. At the completion of the surgery, the individual outcomes will be assessed.
arm group label: Fluoroscopy
arm group type: Other
description: Technologist control of fluoroscopy Surgeon control of fluoroscopy
intervention type: Procedure
intervention name: Technologist control of fluoroscopy
description: Technologist control of fluoroscopy
arm group label: Fluoroscopy
intervention type: Procedure
intervention name: Surgeon control of fluoroscopy
description: Surgeon control of fluoroscopy
arm group label: Fluoroscopy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 25 Years
healthy volunteers: No
last name: Caleb Nelson, MD, MPH
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Caleb Nelson
investigator title: Caleb Nelson MD, MPH
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Urolithiasis
mesh term: Urinary Calculi