<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/NCT01705405</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC 12 06</org_study_id>
    <nct_id>NCT01705405</nct_id>
  </id_info>
  <brief_title>Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery</brief_title>
  <acronym>FEE</acronym>
  <official_title>Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdministrateurCIC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TIMC-IMAG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Visualize surgical needles inserted in the prostate, under the ultrasound modality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to help the surgeon to remove the prostate during a laparoscopic intervention, our&#xD;
      goal is to provide an innovative medical device that merges intra-operative ultrasound and&#xD;
      endoscopic images.&#xD;
&#xD;
      We have already achieved the proof of concept of a device that merges ultrasound and&#xD;
      endoscopic images. The objectives of this clinical trial are to accompany the maturation of&#xD;
      the fusion device and to make the initial assessments of its Medical Service.&#xD;
&#xD;
      The main difficulty is to visualize markers (surgical needles) under both modalities , in&#xD;
      order to merge them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    due to a problem of device&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)</measure>
    <time_frame>1year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of data(ultrasound and endoscopic) on which the merging works</measure>
    <time_frame>1year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of accurate merging</measure>
    <time_frame>1year</time_frame>
    <description>the merging is accurate if its error is under 5mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of mistaken segmentation of the vesical neck in the endoscopic image</measure>
    <time_frame>1year</time_frame>
    <description>The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>medical device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>medical device to acquire ultrasound and endoscopic images during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Software for acquiring ultrasound and endoscopic images</intervention_name>
    <description>Use of a medical device to acquire ultrasound and endoscopic images</description>
    <arm_group_label>medical device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  of-age patient&#xD;
&#xD;
          -  patient for whom a radical prostatectomy is planned&#xD;
&#xD;
          -  patient with a prostate volume between 30g and 100g&#xD;
&#xD;
          -  patient affiliated to the social security or equivalent&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication&#xD;
&#xD;
          -  patient who has undergone a significant prostate resection&#xD;
&#xD;
          -  patient who has undergone a prostate irradiation&#xD;
&#xD;
          -  patient concerned by the L1121-6 à 8 of the health public code&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Alexandre Long, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology, University hospital of Grenoble</name>
      <address>
        <city>Grenoble</city>
        <state>Isère</state>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.cic-it-grenoble.fr/</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 17, 2016</last_update_submitted>
  <last_update_submitted_qc>October 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Grenoble</investigator_affiliation>
    <investigator_full_name>AdministrateurCIC</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>prostate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT01705405
org study id: DCIC 12 06
nct id: NCT01705405
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Visualize surgical needles inserted in the prostate, under the ultrasound modality.
In order to help the surgeon to remove the prostate during a laparoscopic intervention, our
      goal is to provide an innovative medical device that merges intra-operative ultrasound and
      endoscopic images.

      We have already achieved the proof of concept of a device that merges ultrasound and
      endoscopic images. The objectives of this clinical trial are to accompany the maturation of
      the fusion device and to make the initial assessments of its Medical Service.

      The main difficulty is to visualize markers (surgical needles) under both modalities , in
      order to merge them.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
time frame: 1year
measure: Percent of data(ultrasound and endoscopic) on which the merging works
time frame: 1year
measure: Percent of accurate merging
time frame: 1year
description: the merging is accurate if its error is under 5mm
measure: Percent of mistaken segmentation of the vesical neck in the endoscopic image
time frame: 1year
description: The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume
arm group label: medical device
arm group type: Experimental
description: medical device to acquire ultrasound and endoscopic images during surgery
intervention type: Device
intervention name: Software for acquiring ultrasound and endoscopic images
description: Use of a medical device to acquire ultrasound and endoscopic images
arm group label: medical device
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jean-Alexandre Long, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
url: http://www.cic-it-grenoble.fr/
description: Related Info
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Grenoble
investigator full name: AdministrateurCIC
investigator title: principal investigator
mesh term: Prostatic Neoplasms