<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/NCT02196649</url>
  </required_header>
  <id_info>
    <org_study_id>HREC2014/5/4.2(3971)</org_study_id>
    <nct_id>NCT02196649</nct_id>
  </id_info>
  <brief_title>Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial</brief_title>
  <acronym>CuRB</acronym>
  <official_title>Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal&#xD;
      Resection (EMR) site following complete removal of the lesion, or will not receive clips and&#xD;
      proceed with standard of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outlined literature suggests that colonic post EMR bleeding may be prevented by the use&#xD;
      of prophylactic endoscopic clips. There has thus far been no prospective study to confirm&#xD;
      this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled&#xD;
      trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for&#xD;
      the purpose of preventing delayed bleeding in colonic wide field EMR (lesions&gt;20mm). Given&#xD;
      the significantly increased rate of bleeding in the proximal colon, clip placement in this&#xD;
      location may have the greatest benefit. If it is proven that such a prophylactic technique is&#xD;
      effective and safe, it may lead to significantly decreased patient morbidity and health care&#xD;
      resources associated with the management delayed bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Post-Procedural Bleeding</measure>
    <time_frame>14 days</time_frame>
    <description>Clinically significant post colonic wide-field EMR bleeding (CSPEB)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety success</measure>
    <time_frame>18 months</time_frame>
    <description>Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Colonic Polyps</condition>
  <arm_group>
    <arm_group_label>Endoscopic Clipping</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomised to the arm will receive endoscopic clips to their defect following EMR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Endoscopic Clipping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These participants will receive standard of care practice only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic Clip</intervention_name>
    <arm_group_label>Endoscopic Clipping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Can give informed consent to trial participation&#xD;
&#xD;
          -  Lesion size greater than 20 mm&#xD;
&#xD;
          -  Lesion proximal to and inclusive of mid transverse colon&#xD;
&#xD;
          -  Laterally spreading or sessile polyp morphology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous resection or attempted resection of lesion&#xD;
&#xD;
          -  Clip deployed prior to the completion of the EMR&#xD;
&#xD;
          -  Major intraprocedural bleeding not treatable by coagulation&#xD;
&#xD;
          -  Endoscopic appearance of invasive malignancy&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)&#xD;
&#xD;
          -  Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior&#xD;
             to procedure&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Grade IV-V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Bourke, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Sydney Local Health District</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westmead Endoscopy Unit</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</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 Gastrointestinal Endoscopy</investigator_title>
  </responsible_party>
  <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/NCT02196649
org study id: HREC2014/5/4.2(3971)
nct id: NCT02196649
lead sponsor: 
has dmc: No
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal
      Resection (EMR) site following complete removal of the lesion, or will not receive clips and
      proceed with standard of care.
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use
      of prophylactic endoscopic clips. There has thus far been no prospective study to confirm
      this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled
      trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for
      the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given
      the significantly increased rate of bleeding in the proximal colon, clip placement in this
      location may have the greatest benefit. If it is proven that such a prophylactic technique is
      effective and safe, it may lead to significantly decreased patient morbidity and health care
      resources associated with the management delayed bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Post-Procedural Bleeding
time frame: 14 days
description: Clinically significant post colonic wide-field EMR bleeding (CSPEB)
measure: Safety success
time frame: 18 months
description: Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate
arm group label: Endoscopic Clipping
arm group type: Experimental
description: Participants randomised to the arm will receive endoscopic clips to their defect following EMR.
arm group label: No Endoscopic Clipping
arm group type: No Intervention
description: These participants will receive standard of care practice only.
intervention type: Device
intervention name: Endoscopic Clip
arm group label: Endoscopic Clipping
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Michael J Bourke, MBBS
role: Principal Investigator
affiliation: Western Sydney Local Health District
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 Gastrointestinal Endoscopy
mesh term: Colonic Polyps