<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/NCT01665898</url>
  </required_header>
  <id_info>
    <org_study_id>IncheonSMH</org_study_id>
    <secondary_id>OC12OISI0067</secondary_id>
    <nct_id>NCT01665898</nct_id>
  </id_info>
  <brief_title>Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps</brief_title>
  <official_title>Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incheon St.Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incheon St.Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon&#xD;
      polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy,&#xD;
      additional EMR was performed at the polypectomy site to assess the presence of residual polyp&#xD;
      tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps</measure>
    <time_frame>up to 3 years</time_frame>
    <description>We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy</measure>
    <time_frame>participants will be followed up for 1 month</time_frame>
    <description>We will investigate bleeding rate after removal of colon polyps by these two methods. Bleeding rate will be the number of patients who showed significant bleeding after the procedure divided by the total number of patients who will receive the procedure. Significant bleeding was determined to be ongoing bleeding for more than 30 seconds after the procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Colon Polyps</condition>
  <arm_group>
    <arm_group_label>Cold biopsy forceps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cold biopsy forceps for removal of colon polyps</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold Snare Biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cold snare biopsy for removal of colon polyps</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold Biopsy forceps</intervention_name>
    <description>removal of polyps using cold biopsy forceps</description>
    <arm_group_label>Cold biopsy forceps</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold snare biopsy</intervention_name>
    <description>Removal of colon polyps using cold snare biopsy</description>
    <arm_group_label>Cold Snare Biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients older than 40 years old and&#xD;
&#xD;
          -  patients who are receiving colonoscopies and&#xD;
&#xD;
          -  patients who have colon polyps&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have not agreed to the study&#xD;
&#xD;
          -  patients with bleeding tendencies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo-In Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Incheon St.Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Incheon St. Mary's Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>March 24, 2015</last_update_submitted>
  <last_update_submitted_qc>March 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Incheon St.Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Joon Sung Kim</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>cold biopsy forceps</keyword>
  <keyword>cold snare biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <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/NCT01665898
org study id: IncheonSMH
secondary id: OC12OISI0067
nct id: NCT01665898
lead sponsor: 
has dmc: Yes
Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon
      polyps.
Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy,
      additional EMR was performed at the polypectomy site to assess the presence of residual polyp
      tissue.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
time frame: up to 3 years
description: We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.
measure: Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
time frame: participants will be followed up for 1 month
description: We will investigate bleeding rate after removal of colon polyps by these two methods. Bleeding rate will be the number of patients who showed significant bleeding after the procedure divided by the total number of patients who will receive the procedure. Significant bleeding was determined to be ongoing bleeding for more than 30 seconds after the procedure
arm group label: Cold biopsy forceps
arm group type: Active Comparator
description: Cold biopsy forceps for removal of colon polyps
arm group label: Cold Snare Biopsy
arm group type: Active Comparator
description: Cold snare biopsy for removal of colon polyps
intervention type: Procedure
intervention name: Cold Biopsy forceps
description: removal of polyps using cold biopsy forceps
arm group label: Cold biopsy forceps
intervention type: Procedure
intervention name: Cold snare biopsy
description: Removal of colon polyps using cold snare biopsy
arm group label: Cold Snare Biopsy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bo-In Lee
role: Principal Investigator
affiliation: Incheon St.Mary's Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Incheon St.Mary's Hospital
investigator full name: Joon Sung Kim
investigator title: Instructor
mesh term: Polyps
mesh term: Colonic Polyps