<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/NCT03241290</url>
  </required_header>
  <id_info>
    <org_study_id>38RC17.010</org_study_id>
    <secondary_id>2017-A00103-50</secondary_id>
    <nct_id>NCT03241290</nct_id>
  </id_info>
  <brief_title>Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice</brief_title>
  <official_title>Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Investigation Centre for Innovative Technology Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and&#xD;
      its ability to be used during surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Expected performance of TED developped technology compared to current equipment (intensifier&#xD;
      tube) represent a significant improvement; especially in term of image rendering, irradiation&#xD;
      dose reduction and ergonomy.&#xD;
&#xD;
      THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which&#xD;
      objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates&#xD;
      its ability to be used during Orthopedic, neurological and neurological surgeries.&#xD;
&#xD;
      Patient included in the study will have a surgery during which C-ARM is used. This study&#xD;
      doesn't modify the medical care of the patient.&#xD;
&#xD;
      After each surgery, a digital scale of image quality will be filled by the surgeon for each&#xD;
      aquisition. Other feedback questionnaires regarding the suitability of the device and the&#xD;
      satisfaction of the surgeon will also be completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Digital scale of image quality</measure>
    <time_frame>up to 5 hours</time_frame>
    <description>Digital scale of image quality completed for each acquisition by the surgeon</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>C.Surgical Procedure</condition>
  <arm_group>
    <arm_group_label>Use of C-ARM ARCO FP-Rk521S</arm_group_label>
    <description>C-ARM ARCO FP-Rk521S is mobile X-ray device that combines a X-Ray sensor and a sensor management software used during surgeries for real-time imaging.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who undergo surgery (orthopedic, urological or neurological surgery)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject having signed the non-objection form;&#xD;
&#xD;
          -  Requiring one of the following surgical procedures:&#xD;
&#xD;
               -  Urology: soft ureteroscopy, uteroscopy, sacral neuromodulation, JJ sent&#xD;
                  placement.&#xD;
&#xD;
               -  Orthopedics: vertebroplasty, gamma nail placement, sacro-iliac screw fixation.&#xD;
&#xD;
               -  Neurology: spinal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who refuse to participate in the study;&#xD;
&#xD;
          -  Who are under legal protection measure or unable to express their consent&#xD;
             (guardianship, curatorship);&#xD;
&#xD;
          -  Deprived of liberty by judicial or administrative decision.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Moreau-Gaudry, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital, Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.cic-it.fr/cic-it-grenoble.php</url>
    <description>Clinical Investigation Centre for Innovative Technology Network website</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>March 28, 2019</last_update_submitted>
  <last_update_submitted_qc>March 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>C-arm</keyword>
  <keyword>Medical Imaging Device</keyword>
  <keyword>Radiological</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03241290
org study id: 38RC17.010
secondary id: 2017-A00103-50
nct id: NCT03241290
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and
      its ability to be used during surgery.
Expected performance of TED developped technology compared to current equipment (intensifier
      tube) represent a significant improvement; especially in term of image rendering, irradiation
      dose reduction and ergonomy.

      THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which
      objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates
      its ability to be used during Orthopedic, neurological and neurological surgeries.

      Patient included in the study will have a surgery during which C-ARM is used. This study
      doesn't modify the medical care of the patient.

      After each surgery, a digital scale of image quality will be filled by the surgeon for each
      aquisition. Other feedback questionnaires regarding the suitability of the device and the
      satisfaction of the surgeon will also be completed.
observational model: Cohort
time perspective: Prospective
measure: Digital scale of image quality
time frame: up to 5 hours
description: Digital scale of image quality completed for each acquisition by the surgeon
arm group label: Use of C-ARM ARCO FP-Rk521S
description: C-ARM ARCO FP-Rk521S is mobile X-ray device that combines a X-Ray sensor and a sensor management software used during surgeries for real-time imaging.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre Moreau-Gaudry, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
url: http://www.cic-it.fr/cic-it-grenoble.php
description: Clinical Investigation Centre for Innovative Technology Network website
responsible party type: Sponsor
sharing ipd: Undecided