<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/NCT01688557</url>
  </required_header>
  <id_info>
    <org_study_id>Innovations in colonoscopy</org_study_id>
    <nct_id>NCT01688557</nct_id>
  </id_info>
  <brief_title>Trial on Innovative Technologies in Colonoscopy</brief_title>
  <acronym>RCT-IC</acronym>
  <official_title>Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jagiellonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Specialist Diagnostic and Therapeutic Center MEDICINA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jagiellonian University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial will compare results of screening colonoscopy performed by means of conventional&#xD;
      colonoscopy and using new visualisation techniques during endoscopic examination.&#xD;
&#xD;
        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning&#xD;
           (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band&#xD;
           imaging (NBI) will be used for innovative colonoscopies&#xD;
&#xD;
        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used&#xD;
           for conventional colonoscopies Endoscopists will archive all images and establish&#xD;
           presumptive diagnosis based on the results of different visualisation techniques. All&#xD;
           endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological&#xD;
           lesions will be performed to establish final diagnosis. The main outcome measure is&#xD;
           diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be&#xD;
      randomly assigned to innovative or conventional examination. Randomization will be based on&#xD;
      computer-generated randomization lists. All patients will be blinded so they will not know&#xD;
      which techniques will be used to assess lesions found in colon. In innovative colonoscopy&#xD;
      group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and&#xD;
      classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken&#xD;
      from all lesion and endoscopic diagnosis will be compared with final histological diagnosis.&#xD;
      Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and&#xD;
      Youden index will be calculated. As secondary endpoints total examination time, coecal&#xD;
      intubation rate and pain intensity (VAS scale) will be established. This study will help to&#xD;
      establish whether new technologies used during colonoscopy may improve diagnostic&#xD;
      possibilities and whether they prolong examination time or lead to increase of pain intensity&#xD;
      afterwards.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total examination time</measure>
    <time_frame>8-20 minutes</time_frame>
    <description>Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coecal intubation time</measure>
    <time_frame>5-15 minutes</time_frame>
    <description>Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity (VAS scale)</measure>
    <time_frame>0-10</time_frame>
    <description>Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sensitivity of innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Specificity of innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Positive predictive Value (PPV) od innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Negative predicting value (NPV) of innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Youden's index for innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Diagnostic odds ratio (DOR) for innovative colonoscopy</measure>
    <time_frame>1 year</time_frame>
    <description>The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Likelihood ratio for positive test results (LR+)</measure>
    <time_frame>1 year</time_frame>
    <description>The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Likelihood ratio for negative test results (LR-)</measure>
    <time_frame>1 year</time_frame>
    <description>The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <other_outcome>
    <measure>Area under the ROC curve (AUC)</measure>
    <time_frame>1 year</time_frame>
    <description>Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Polyps</condition>
  <condition>Neoplasms</condition>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Innovative colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional colonoscopy performed without innovative techniques assessed in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)</intervention_name>
    <description>NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.</description>
    <arm_group_label>Innovative colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional colonoscopy (Olympus CF-H180DL)</intervention_name>
    <description>Conventional colonoscopy performed without innovative techniques used in experimental arm.</description>
    <arm_group_label>Conventional colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  no previous abdominal surgery&#xD;
&#xD;
          -  no colonoscopy during last 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 40 and &gt; 65 years&#xD;
&#xD;
          -  large bowel resection in history&#xD;
&#xD;
          -  colonoscopy performed during last 10 years&#xD;
&#xD;
          -  contraindications for general anaesthesia&#xD;
&#xD;
          -  ASA &gt; IV&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  confirmed neoplastic disease&#xD;
&#xD;
          -  cirrhosis (Child B or C) or ascites&#xD;
&#xD;
          -  immunosuppressive therapy or steroids intake&#xD;
&#xD;
          -  malabsorption syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miroslaw Szura, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>I Department of General Surgery, Jagiellonian University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radoslaw Pach, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>I Department of General Surgery, Jagiellonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Specialist Diagnostic and Therapeutic Center MEDICINA</name>
      <address>
        <city>Krakow</city>
        <state>Malopolska</state>
        <zip>30-307</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I Department of General Surgery, Jagiellonian University</name>
      <address>
        <city>Krakow</city>
        <state>Malopolska</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>http://www.rydygier.cm-uj.krakow.pl/</url>
    <description>The official site of the I Department of General Surgery, Jagiellonian University</description>
  </link>
  <link>
    <url>http://www.medicina.pl</url>
    <description>The official site of Specialist Diagnostic and Therapeutic Center MEDICINA</description>
  </link>
  <results_reference>
    <citation>Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4.</citation>
    <PMID>25840894</PMID>
  </results_reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>October 6, 2016</last_update_submitted>
  <last_update_submitted_qc>October 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jagiellonian University</investigator_affiliation>
    <investigator_full_name>Miroslaw Szura</investigator_full_name>
    <investigator_title>Assisstant Professor</investigator_title>
  </responsible_party>
  <keyword>narrow band imaging</keyword>
  <keyword>dual focus</keyword>
  <keyword>responsive insertion technique</keyword>
  <keyword>scope guide</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>colorectal cancer screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT01688557
org study id: Innovations in colonoscopy
nct id: NCT01688557
lead sponsor: 
collaborator: 
has dmc: No
The trial will compare results of screening colonoscopy performed by means of conventional
      colonoscopy and using new visualisation techniques during endoscopic examination.

        -  Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning
           (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band
           imaging (NBI) will be used for innovative colonoscopies

        -  Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used
           for conventional colonoscopies Endoscopists will archive all images and establish
           presumptive diagnosis based on the results of different visualisation techniques. All
           endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological
           lesions will be performed to establish final diagnosis. The main outcome measure is
           diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.
A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be
      randomly assigned to innovative or conventional examination. Randomization will be based on
      computer-generated randomization lists. All patients will be blinded so they will not know
      which techniques will be used to assess lesions found in colon. In innovative colonoscopy
      group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and
      classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken
      from all lesion and endoscopic diagnosis will be compared with final histological diagnosis.
      Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and
      Youden index will be calculated. As secondary endpoints total examination time, coecal
      intubation rate and pain intensity (VAS scale) will be established. This study will help to
      establish whether new technologies used during colonoscopy may improve diagnostic
      possibilities and whether they prolong examination time or lead to increase of pain intensity
      afterwards.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic accuracy of innovative colonoscopy
time frame: 1 year
description: Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.
measure: Total examination time
time frame: 8-20 minutes
description: Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.
measure: Coecal intubation time
time frame: 5-15 minutes
description: Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
measure: Pain intensity (VAS scale)
time frame: 0-10
description: Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.
measure: Sensitivity of innovative colonoscopy
time frame: 1 year
description: The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.
measure: Specificity of innovative colonoscopy
time frame: 1 year
description: The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.
measure: Positive predictive Value (PPV) od innovative colonoscopy
time frame: 1 year
description: The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Negative predicting value (NPV) of innovative colonoscopy
time frame: 1 year
description: The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Youden's index for innovative colonoscopy
time frame: 1 year
description: The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Diagnostic odds ratio (DOR) for innovative colonoscopy
time frame: 1 year
description: The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Likelihood ratio for positive test results (LR+)
time frame: 1 year
description: The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Likelihood ratio for negative test results (LR-)
time frame: 1 year
description: The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
measure: Area under the ROC curve (AUC)
time frame: 1 year
description: Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.
arm group label: Innovative colonoscopy
arm group type: Experimental
description: Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
arm group label: Conventional colonoscopy
arm group type: Active Comparator
description: Conventional colonoscopy performed without innovative techniques assessed in this study.
intervention type: Device
intervention name: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
description: NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.
arm group label: Innovative colonoscopy
intervention type: Device
intervention name: Conventional colonoscopy (Olympus CF-H180DL)
description: Conventional colonoscopy performed without innovative techniques used in experimental arm.
arm group label: Conventional colonoscopy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Miroslaw Szura, MD, PhD
role: Principal Investigator
affiliation: I Department of General Surgery, Jagiellonian University
last name: Radoslaw Pach, MD, PhD
role: Study Chair
affiliation: I Department of General Surgery, Jagiellonian University
facility: 
facility: 
country: Poland
url: http://www.rydygier.cm-uj.krakow.pl/
description: The official site of the I Department of General Surgery, Jagiellonian University
url: http://www.medicina.pl
description: The official site of Specialist Diagnostic and Therapeutic Center MEDICINA
citation: Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4.
PMID: 25840894
responsible party type: Principal Investigator
investigator affiliation: Jagiellonian University
investigator full name: Miroslaw Szura
investigator title: Assisstant Professor
mesh term: Inflammatory Bowel Diseases