<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/NCT03758872</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A01397-48</org_study_id>
    <nct_id>NCT03758872</nct_id>
  </id_info>
  <brief_title>CUFF-assisted Colonoscopy vs Standard Colonoscopy</brief_title>
  <acronym>CUFF-TROCADERO</acronym>
  <official_title>USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique du Trocadéro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique du Trocadéro</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV)&#xD;
      to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.&#xD;
&#xD;
      This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in&#xD;
      prospective group and 517 without ECV in retrospective group&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2018</start_date>
  <completion_date type="Actual">September 26, 2019</completion_date>
  <primary_completion_date type="Actual">September 26, 2019</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>detection of polyp or adenoma with cuff</measure>
    <time_frame>during procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>POLYP DETECTION RATE</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>morbidity : perforation rate</measure>
    <time_frame>21 DAYS AFTER PROCEDURE</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CAECAL INTUBATION RATE</measure>
    <time_frame>DURING PROCEDURE</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIME TO REACH CAECUM</measure>
    <time_frame>DURING PROCEDURE</time_frame>
    <description>SEC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WITHDRAWAL TIME</measure>
    <time_frame>DURING PROCEDURE</time_frame>
    <description>SEC</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1034</enrollment>
  <condition>Colonic Polyp</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>historical comparaison whithout cuff</arm_group_label>
    <description>517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cuff assisted colonoscopy(with cuff use of endocuff vision second generation)</intervention_name>
    <description>this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps</description>
    <arm_group_label>historical comparaison whithout cuff</arm_group_label>
    <other_name>colonoscopy with polypectomy or mucosectomy</other_name>
    <other_name>standard colonoscopy ( without use of endocuff vision)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient of all participating physicians for total colonoscopic exploration over the study&#xD;
        periods&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient scheduled for total colonoscopic exploration, during the period study&#xD;
&#xD;
          -  Patient over or equal to 18 years&#xD;
&#xD;
          -  ASA 1, ASA 2, ASA 3&#xD;
&#xD;
          -  No participation in another clinical study&#xD;
&#xD;
          -  Certificate of non opposition signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under 18 years old&#xD;
&#xD;
          -  ASA 4, ASA 5&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patient with coagulation abnormalities preventing polypectomy: prothrombin level &lt;50%,&#xD;
             -Platelets &lt;50000 / mm3, effective anti-coagulation in progress, clopidogrel in&#xD;
             progress.&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Known colonic stenosis&#xD;
&#xD;
          -  Diverticulitis less than 6 weeks old&#xD;
&#xD;
          -  Patient unable to give consent or protected by law&#xD;
&#xD;
          -  Opposition expressed for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique Du Trocadero</name>
      <address>
        <city>Paris</city>
        <zip>75016</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT03758872
org study id: 2018-A01397-48
nct id: NCT03758872
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV)
      to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.

      This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in
      prospective group and 517 without ECV in retrospective group
observational model: Cohort
time perspective: Prospective
measure: detection of polyp or adenoma with cuff
time frame: during procedure
measure: POLYP DETECTION RATE
time frame: during procedure
measure: morbidity : perforation rate
time frame: 21 DAYS AFTER PROCEDURE
measure: CAECAL INTUBATION RATE
time frame: DURING PROCEDURE
measure: TIME TO REACH CAECUM
time frame: DURING PROCEDURE
description: SEC
measure: WITHDRAWAL TIME
time frame: DURING PROCEDURE
description: SEC
arm group label: historical comparaison whithout cuff
description: 517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection
intervention type: Diagnostic Test
intervention name: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)
description: this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps
arm group label: historical comparaison whithout cuff
other name: colonoscopy with polypectomy or mucosectomy
other name: standard colonoscopy ( without use of endocuff vision)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Polyps
mesh term: Colonic Polyps
sharing ipd: No