<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/NCT03807089</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000677</org_study_id>
    <nct_id>NCT03807089</nct_id>
  </id_info>
  <brief_title>Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope</brief_title>
  <official_title>Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pentax Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the new colonoscope that provides both a&#xD;
      traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon&#xD;
      can detect more polyps than a standard colonoscope that only provides a forward-facing view.&#xD;
      The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax&#xD;
      Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma&#xD;
      detection rates in human subjects undergoing colonoscopy for polyp surveillance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">May 11, 2017</completion_date>
  <primary_completion_date type="Actual">May 11, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With At Least One Adenoma</measure>
    <time_frame>1 hour</time_frame>
    <description>Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Polyp Detection Rate</measure>
    <time_frame>1 hour</time_frame>
    <description>Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Adenomas Identified Per Patient With Polyps</measure>
    <time_frame>1 hour</time_frame>
    <description>Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Size of Polyps Detected</measure>
    <time_frame>1 hour</time_frame>
    <description>Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).</description>
  </other_outcome>
  <other_outcome>
    <measure>Size of Adenomas Detected</measure>
    <time_frame>1 hour</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">283</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Short-Turn Radius Colonoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Pediatric Colonoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Pediatric Colonoscope</intervention_name>
    <arm_group_label>Conventional Pediatric Colonoscope</arm_group_label>
    <other_name>Pentax Model EG-2490K</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Short-Turn Radius Colonoscope</intervention_name>
    <arm_group_label>Short-Turn Radius Colonoscope</arm_group_label>
    <other_name>Pentax Model EC-3490TLi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to provide Informed Consent&#xD;
&#xD;
          -  Age &gt; 40&#xD;
&#xD;
          -  Surveillance Colonoscopy (History of Adenomas)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor or Fair Bowel Prep&#xD;
&#xD;
          -  Difficult First Insertion&#xD;
&#xD;
          -  Familial Polyposis&#xD;
&#xD;
          -  Inflammatory Bowel Disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active GI Bleeding&#xD;
&#xD;
          -  Prior colonic or rectal resection&#xD;
&#xD;
          -  Conserved Sattus&#xD;
&#xD;
          -  Colonoscopy less than 3 years ago&#xD;
&#xD;
          -  Screening Colonoscopy&#xD;
&#xD;
          -  Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation,&#xD;
             change in bowel habits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norman S Nishioka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.</citation>
    <PMID>8978338</PMID>
  </reference>
  <reference>
    <citation>Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.</citation>
    <PMID>8978337</PMID>
  </reference>
  <reference>
    <citation>Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.</citation>
    <PMID>19075198</PMID>
  </reference>
  <reference>
    <citation>DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.</citation>
    <PMID>20189513</PMID>
  </reference>
  <reference>
    <citation>Kessler WR, Rex DK. Impact of bending section length on insertion and retroflexion properties of pediatric and adult colonoscopes. Am J Gastroenterol. 2005 Jun;100(6):1290-5. doi: 10.1111/j.1572-0241.2005.41454.x.</citation>
    <PMID>15929759</PMID>
  </reference>
  <reference>
    <citation>Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.</citation>
    <PMID>20018280</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>May 29, 2019</results_first_submitted>
  <results_first_submitted_qc>June 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2019</results_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Norman Nishioka, MD</investigator_full_name>
    <investigator_title>Director of Endoscopy</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>colon cancer screening</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 13, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03807089/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>89 subjects were excluded (poor bowel preparation [n = 45], prior colonic resection [n = 3], difficult first insertion [n=45], not over 40 [n = 1], no history of adenomatous colorectal polyps [n = 1], device related reasons [n = 1])</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Short-Turn Radius Colonoscope</title>
          <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
        </group>
        <group group_id="P2">
          <title>Conventional Pediatric Colonoscope</title>
          <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Short-Turn Radius Colonoscope</title>
          <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
        </group>
        <group group_id="B2">
          <title>Conventional Pediatric Colonoscope</title>
          <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="194"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.2" spread="8.13"/>
                    <measurement group_id="B2" value="65.8" spread="8.38"/>
                    <measurement group_id="B3" value="65.9" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="93"/>
                    <count group_id="B3" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With At Least One Adenoma</title>
        <description>Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short-Turn Radius Colonoscope</title>
            <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
          </group>
          <group group_id="O2">
            <title>Conventional Pediatric Colonoscope</title>
            <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With At Least One Adenoma</title>
          <description>Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Polyp Detection Rate</title>
        <description>Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short-Turn Radius Colonoscope</title>
            <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
          </group>
          <group group_id="O2">
            <title>Conventional Pediatric Colonoscope</title>
            <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Polyp Detection Rate</title>
          <description>Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Adenomas Identified Per Patient With Polyps</title>
        <description>Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short-Turn Radius Colonoscope</title>
            <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
          </group>
          <group group_id="O2">
            <title>Conventional Pediatric Colonoscope</title>
            <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Adenomas Identified Per Patient With Polyps</title>
          <description>Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.</description>
          <units>Number of Adenomas Per Patient</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.48" spread="2.05"/>
                    <measurement group_id="O2" value="2.50" spread="1.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Size of Polyps Detected</title>
        <description>Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).</description>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short-Turn Radius Colonoscope</title>
            <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
          </group>
          <group group_id="O2">
            <title>Conventional Pediatric Colonoscope</title>
            <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Size of Polyps Detected</title>
          <description>Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.89" spread="2.92"/>
                    <measurement group_id="O2" value="4.50" spread="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Size of Adenomas Detected</title>
        <time_frame>1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Short-Turn Radius Colonoscope</title>
            <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
          </group>
          <group group_id="O2">
            <title>Conventional Pediatric Colonoscope</title>
            <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Size of Adenomas Detected</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.15" spread="3.04"/>
                    <measurement group_id="O2" value="4.69" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data were collected during the procedure, an average of 1 hour.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Short-Turn Radius Colonoscope</title>
          <description>Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.&#xD;
Short-Turn Radius Colonoscope</description>
        </group>
        <group group_id="E2">
          <title>Conventional Pediatric Colonoscope</title>
          <description>Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.&#xD;
Conventional Pediatric Colonoscope</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Norman Nishioka</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-4422</phone>
      <email>nnishioka@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03807089
org study id: 2014P000677
nct id: NCT03807089
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine whether the new colonoscope that provides both a
      traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon
      can detect more polyps than a standard colonoscope that only provides a forward-facing view.
      The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax
      Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma
      detection rates in human subjects undergoing colonoscopy for polyp surveillance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Patients With At Least One Adenoma
time frame: 1 hour
description: Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
measure: Overall Polyp Detection Rate
time frame: 1 hour
description: Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
measure: Mean Number of Adenomas Identified Per Patient With Polyps
time frame: 1 hour
description: Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.
measure: Size of Polyps Detected
time frame: 1 hour
description: Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).
measure: Size of Adenomas Detected
time frame: 1 hour
arm group label: Short-Turn Radius Colonoscope
arm group type: Experimental
description: Colonoscopy performed with Short-Turn Radius Colonoscope. The colonoscope will provide a forward-facing view of the colon during advancement to the cecum (standard of care). The scope will then be withdrawn all the way to the rectum and the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and be withdrawn using the retrograde view.
arm group label: Conventional Pediatric Colonoscope
arm group type: Active Comparator
description: Colonoscopy will be performed with a conventional pediatric colonoscope. During withdrawal, the colon will be inspected using the forward-facing view (standard of care). The colonoscope will then be re-advanced to the cecum and again withdrawn using the forward-facing view.
intervention type: Device
intervention name: Conventional Pediatric Colonoscope
arm group label: Conventional Pediatric Colonoscope
other name: Pentax Model EG-2490K
intervention type: Device
intervention name: Short-Turn Radius Colonoscope
arm group label: Short-Turn Radius Colonoscope
other name: Pentax Model EC-3490TLi
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Norman S Nishioka, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
citation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
PMID: 8978338
citation: Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.
PMID: 8978337
citation: Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
PMID: 19075198
citation: DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
PMID: 20189513
citation: Kessler WR, Rex DK. Impact of bending section length on insertion and retroflexion properties of pediatric and adult colonoscopes. Am J Gastroenterol. 2005 Jun;100(6):1290-5. doi: 10.1111/j.1572-0241.2005.41454.x.
PMID: 15929759
citation: Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.
PMID: 20018280
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Norman Nishioka, MD
investigator title: Director of Endoscopy
mesh term: Adenoma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 