<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/NCT03243669</url>
  </required_header>
  <id_info>
    <org_study_id>S52580</org_study_id>
    <nct_id>NCT03243669</nct_id>
  </id_info>
  <brief_title>High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps</brief_title>
  <official_title>High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      Over the last years a number of new endoscopic imaging modalities have been introduced&#xD;
      (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new&#xD;
      imaging techniques, the investigators aimed to investigate their use for the detection of&#xD;
      polyps during colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">June 30, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate (ADR)</measure>
    <time_frame>7-10 days</time_frame>
    <description>Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adenomas</measure>
    <time_frame>7-10 days</time_frame>
    <description>Adenoma per colonoscopy rate (APCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of adenomas</measure>
    <time_frame>7-10 days</time_frame>
    <description>Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">2146</enrollment>
  <condition>Colonic Adenoma</condition>
  <arm_group>
    <arm_group_label>Fujinon standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fujinon HD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fujinon high-definition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fujinon HD + VC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fujinon high-definition + virtual chromoendoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olympus standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Olympus HD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olympus high-definition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olympus VC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olympus virtual chromoendoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olympus HD + VC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Olympus high-definition + virtual chromoendoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentax standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentax HD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pentax high-definition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentax VC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pentax virtual chromoendoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentax HD + VC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pentax high-definition + virtual chromoendoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>High-definition</intervention_name>
    <description>High-definition colonoscopy</description>
    <arm_group_label>Fujinon HD</arm_group_label>
    <arm_group_label>Fujinon HD + VC</arm_group_label>
    <arm_group_label>Olympus HD</arm_group_label>
    <arm_group_label>Olympus HD + VC</arm_group_label>
    <arm_group_label>Pentax HD</arm_group_label>
    <arm_group_label>Pentax HD + VC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Virtual chromoendoscopy</intervention_name>
    <description>Virtual chromoendoscopy</description>
    <arm_group_label>Fujinon HD + VC</arm_group_label>
    <arm_group_label>Olympus HD + VC</arm_group_label>
    <arm_group_label>Olympus VC</arm_group_label>
    <arm_group_label>Pentax HD + VC</arm_group_label>
    <arm_group_label>Pentax VC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard</intervention_name>
    <description>Standard colonoscopy</description>
    <arm_group_label>Fujinon standard</arm_group_label>
    <arm_group_label>Olympus standard</arm_group_label>
    <arm_group_label>Pentax standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referred for colonoscopy&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subtotal colectomy&#xD;
&#xD;
          -  known colorectal tumor or polyp prior to colonoscopy&#xD;
&#xD;
          -  genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis&#xD;
             syndrome, juvenile polyposis, Peutz-Jeghers syndrome&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  primary sclerosering cholangitis&#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>Raf Bisschops, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.</citation>
    <PMID>25448873</PMID>
  </reference>
  <reference>
    <citation>Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.</citation>
    <PMID>28268235</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>High-definition endoscopy</keyword>
  <keyword>Virtual chromoendoscopy</keyword>
  <keyword>Adenoma detection rate (ADR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT03243669
org study id: S52580
nct id: NCT03243669
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Over the last years a number of new endoscopic imaging modalities have been introduced
      (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new
      imaging techniques, the investigators aimed to investigate their use for the detection of
      polyps during colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma detection rate (ADR)
time frame: 7-10 days
description: Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy.
measure: Number of adenomas
time frame: 7-10 days
description: Adenoma per colonoscopy rate (APCR)
measure: Type of adenomas
time frame: 7-10 days
description: Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas
arm group label: Fujinon standard
arm group type: Active Comparator
arm group label: Fujinon HD
arm group type: Active Comparator
description: Fujinon high-definition
arm group label: Fujinon HD + VC
arm group type: Active Comparator
description: Fujinon high-definition + virtual chromoendoscopy
arm group label: Olympus standard
arm group type: Active Comparator
arm group label: Olympus HD
arm group type: Active Comparator
description: Olympus high-definition
arm group label: Olympus VC
arm group type: Active Comparator
description: Olympus virtual chromoendoscopy
arm group label: Olympus HD + VC
arm group type: Active Comparator
description: Olympus high-definition + virtual chromoendoscopy
arm group label: Pentax standard
arm group type: Active Comparator
arm group label: Pentax HD
arm group type: Active Comparator
description: Pentax high-definition
arm group label: Pentax VC
arm group type: Active Comparator
description: Pentax virtual chromoendoscopy
arm group label: Pentax HD + VC
arm group type: Active Comparator
description: Pentax high-definition + virtual chromoendoscopy
intervention type: Diagnostic Test
intervention name: High-definition
description: High-definition colonoscopy
arm group label: Fujinon HD
arm group label: Fujinon HD + VC
arm group label: Olympus HD
arm group label: Olympus HD + VC
arm group label: Pentax HD
arm group label: Pentax HD + VC
intervention type: Diagnostic Test
intervention name: Virtual chromoendoscopy
description: Virtual chromoendoscopy
arm group label: Fujinon HD + VC
arm group label: Olympus HD + VC
arm group label: Olympus VC
arm group label: Pentax HD + VC
arm group label: Pentax VC
intervention type: Diagnostic Test
intervention name: Standard
description: Standard colonoscopy
arm group label: Fujinon standard
arm group label: Olympus standard
arm group label: Pentax standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raf Bisschops, MD PhD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
facility: 
country: Belgium
citation: Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Am J Gastroenterol. 2015 Jan;110(1):72-90. doi: 10.1038/ajg.2014.385. Epub 2014 Dec 2. No abstract available.
PMID: 25448873
citation: Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2017 Apr;49(4):378-397. doi: 10.1055/s-0043-103411. Epub 2017 Mar 7.
PMID: 28268235
responsible party type: Sponsor
mesh term: Adenoma
sharing ipd: No