<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/NCT02966847</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9838</org_study_id>
    <secondary_id>2016-A01353-48</secondary_id>
    <nct_id>NCT02966847</nct_id>
  </id_info>
  <brief_title>Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery</brief_title>
  <acronym>CAVIT</acronym>
  <official_title>Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      In the coming years, an increase in lung nodule resection is expected, particularly in&#xD;
      Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a&#xD;
      device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a&#xD;
      tool whose use is constantly spreading.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop&#xD;
      a new procedure for intraoperative localization of pulmonary nodules in video-assisted&#xD;
      thoracoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2017</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of CBCT</measure>
    <time_frame>the day following the acquisition</time_frame>
    <description>Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of CBCT</measure>
    <time_frame>At the end of the surgery</time_frame>
    <description>Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global image quality</measure>
    <time_frame>the day following the acquisition</time_frame>
    <description>Assessment of image quality is based on an &quot;open label&quot; interpretation of CBCT images by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of image quality of lesions</measure>
    <time_frame>the day following the acquisition</time_frame>
    <description>Assessment of image quality depending on the type of lesion and their location. Interpretation of CBCT images are performed by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Thoracoscopy</condition>
  <arm_group>
    <arm_group_label>CBCT Acquisition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CBCT acquisition</intervention_name>
    <description>Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device</description>
    <arm_group_label>CBCT Acquisition</arm_group_label>
    <other_name>Artis Zeego System®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anesthesia and surgery</intervention_name>
    <description>The anesthesia and surgery will take place according clinical routine practice</description>
    <arm_group_label>CBCT Acquisition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18;&#xD;
&#xD;
          -  patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;&#xD;
&#xD;
          -  Complete preoperative assessment;&#xD;
&#xD;
          -  Patient receiving information about the protocol who did not indicate his/her&#xD;
             opposition to participate;&#xD;
&#xD;
          -  Patient covered by a social insurance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reoperation (history of ipsilateral thoracic surgery);&#xD;
&#xD;
          -  Inability to achieve or obtain a single-lung ventilation during surgery;&#xD;
&#xD;
          -  Adult subject to legal protection (trusteeship, guardianship);&#xD;
&#xD;
          -  Person deprived of liberty.&#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>Simon ROUZE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de RENNES</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.</citation>
    <PMID>33588119</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Video assisted thoracoscopy</keyword>
  <keyword>Cone beam computed tomography</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT02966847
org study id: 35RC16_9838
secondary id: 2016-A01353-48
nct id: NCT02966847
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the coming years, an increase in lung nodule resection is expected, particularly in
      Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a
      device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a
      tool whose use is constantly spreading.
The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop
      a new procedure for intraoperative localization of pulmonary nodules in video-assisted
      thoracoscopic surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assessment of CBCT
time frame: the day following the acquisition
description: Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.
measure: Feasibility of CBCT
time frame: At the end of the surgery
description: Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.
measure: Assessment of global image quality
time frame: the day following the acquisition
description: Assessment of image quality is based on an "open label" interpretation of CBCT images by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)
measure: Assessment of image quality of lesions
time frame: the day following the acquisition
description: Assessment of image quality depending on the type of lesion and their location. Interpretation of CBCT images are performed by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)
arm group label: CBCT Acquisition
arm group type: Experimental
description: The anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars.
intervention type: Procedure
intervention name: CBCT acquisition
description: Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
arm group label: CBCT Acquisition
other name: Artis Zeego System®
intervention type: Procedure
intervention name: Anesthesia and surgery
description: The anesthesia and surgery will take place according clinical routine practice
arm group label: CBCT Acquisition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon ROUZE, MD
role: Principal Investigator
affiliation: CHU Rennes
facility: 
country: France
citation: Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.
PMID: 33588119
responsible party type: Sponsor
mesh term: Anesthetics
sharing ipd: No