<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/NCT02205125</url>
  </required_header>
  <id_info>
    <org_study_id>HREC2013/8/6.6(3797)</org_study_id>
    <nct_id>NCT02205125</nct_id>
  </id_info>
  <brief_title>Cold Polypectomy Site Study</brief_title>
  <official_title>Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Michael Bourke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Sydney Local Health District</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional&#xD;
      method for removal however the snared area after removal can occasionally appear uneven&#xD;
      raising the possibility that complete removal has not occurred. The significance of this&#xD;
      irregularity has not be studied. This study aims to separately sample the irregular area and&#xD;
      determine the constituents while recording how frequently this occurs during routine&#xD;
      colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue&#xD;
      and do not represent polyp tissue left behind.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Frequency and constituents of stalk projections in cold snare polypectomy sites</measure>
    <time_frame>14 days</time_frame>
    <description>Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.</description>
  </primary_outcome>
  <enrollment type="Actual">88</enrollment>
  <condition>Colonic Polyps</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      All polypectomy specimens were submitted for histopathological assessment as per clinical&#xD;
      practice. The biopsy samples from the irregular areas were also submitted in the same&#xD;
      fashion. All specimens are stored as per current clinical practice.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing colonoscopy at a tertiary endoscopy unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing colonoscopy with at least one polyp identified where polypectomy&#xD;
             is planned.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patients where polypectomy is not planned to be undertaken (patients scheduled for&#xD;
             diagnostic colonoscopy only).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bourke, MBBS, FRACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>WSLHD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westmead Hospital Endoscopy Unit</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Western Sydney Local Health District</investigator_affiliation>
    <investigator_full_name>Professor Michael Bourke</investigator_full_name>
    <investigator_title>Director of Endoscopy, Westmead Hospital, Sydney, Australia</investigator_title>
  </responsible_party>
  <keyword>polyp</keyword>
  <keyword>colon</keyword>
  <keyword>polypectomy</keyword>
  <keyword>snare</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Polyps</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/NCT02205125
org study id: HREC2013/8/6.6(3797)
nct id: NCT02205125
lead sponsor: 
has dmc: Yes
Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional
      method for removal however the snared area after removal can occasionally appear uneven
      raising the possibility that complete removal has not occurred. The significance of this
      irregularity has not be studied. This study aims to separately sample the irregular area and
      determine the constituents while recording how frequently this occurs during routine
      colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue
      and do not represent polyp tissue left behind.
observational model: Cohort
time perspective: Prospective
measure: Frequency and constituents of stalk projections in cold snare polypectomy sites
time frame: 14 days
description: Biopsy of post cold snare polypectomy stalk to determine constituents of stalk. This was reviewed 14 days following the procedure.
All polypectomy specimens were submitted for histopathological assessment as per clinical
      practice. The biopsy samples from the irregular areas were also submitted in the same
      fashion. All specimens are stored as per current clinical practice.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Michael Bourke, MBBS, FRACP
role: Principal Investigator
affiliation: WSLHD
facility: 
country: Australia
responsible party type: Sponsor-Investigator
investigator affiliation: Western Sydney Local Health District
investigator full name: Professor Michael Bourke
investigator title: Director of Endoscopy, Westmead Hospital, Sydney, Australia
mesh term: Colonic Polyps