<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/NCT02201147</url>
  </required_header>
  <id_info>
    <org_study_id>2014-04-041</org_study_id>
    <nct_id>NCT02201147</nct_id>
  </id_info>
  <brief_title>Cold Snare Polypectomy Vs. Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps</brief_title>
  <official_title>Prospective Comparison of Cold Snare Polypectomy and Cold Forceps Polypectomy Using Narrow-band Imaging Endoscopy for Diminutive Colorectal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy&#xD;
      using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous study found Cold snare polypectomy a preferable technique in comparison to cold&#xD;
      biopsy for diminutive polyps when assessed for completeness of resection. However, it is&#xD;
      expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or&#xD;
      narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of&#xD;
      the diminutive polyps were completely resected using cold biopsy polypectomy with&#xD;
      chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy&#xD;
      polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.&#xD;
&#xD;
      The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using&#xD;
      Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complete histologic polyp eradication rate</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>rates of tissue retrieval per polyp</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>polypectomy procedure times</measure>
    <time_frame>2 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Polyp of Large Intestine</condition>
  <arm_group>
    <arm_group_label>cold biopsy polypectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold snare polypectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold biopsy polypectomy</intervention_name>
    <description>removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy</description>
    <arm_group_label>cold biopsy polypectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold snare polypectomy</intervention_name>
    <description>removal of eligible polyps using cold snare polypectomy technique</description>
    <arm_group_label>Cold snare polypectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold snare polypectomy</intervention_name>
    <description>mini (10 mm open diameter) size electrosurgical snare without application of electrocautery</description>
    <arm_group_label>Cold snare polypectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold biopsy polypectomy</intervention_name>
    <description>standard- capacity forceps with narrow band imaging endoscopy</description>
    <arm_group_label>cold biopsy polypectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over the age of 20 years undergoing routine colonoscopy (screening,&#xD;
             surveillance, or diagnostic)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients taking antiplatelet or anticoagulant therapy during the past 1 week of the&#xD;
             procedure&#xD;
&#xD;
          -  known coagulopathy&#xD;
&#xD;
          -  history of inflammatory bowel diseases&#xD;
&#xD;
          -  American Society of Anesthesiology class III or more&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bong Min Ko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SoonChunHyang University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital, Bucheon</name>
      <address>
        <city>Bucheon</city>
        <zip>420-767</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>May 2, 2015</last_update_submitted>
  <last_update_submitted_qc>May 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-kyung Park</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02201147
org study id: 2014-04-041
nct id: NCT02201147
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare cold snare polypectomy and cold forceps polypectomy
      using narrow-band imaging endoscopy for removal of diminutive colorectal polyps.
Previous study found Cold snare polypectomy a preferable technique in comparison to cold
      biopsy for diminutive polyps when assessed for completeness of resection. However, it is
      expected that cold biopsy polypectomy with advanced endoscopy, such as chromoendoscopy or
      narrow-band imaging endoscopy, increase completeness of resection. One study showed 90% of
      the diminutive polyps were completely resected using cold biopsy polypectomy with
      chromoendoscopy. However, no study compared cold snare polypectomy and cold biopsy
      polypectomy using Narrow-band Imaging endoscopy for Removal of Diminutive Colorectal Polyps.

      The aim of this study is to compare cold snare polypectomy and Cold biopsy Polypectomy Using
      Narrow-band Imaging Endoscopy for Removal of Diminutive Colorectal Polyps
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: complete histologic polyp eradication rate
time frame: 2 weeks
measure: rates of tissue retrieval per polyp
time frame: 2 weeks
measure: polypectomy procedure times
time frame: 2 weeks
arm group label: cold biopsy polypectomy
arm group type: Experimental
arm group label: Cold snare polypectomy
arm group type: Experimental
intervention type: Procedure
intervention name: Cold biopsy polypectomy
description: removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy
arm group label: cold biopsy polypectomy
intervention type: Procedure
intervention name: Cold snare polypectomy
description: removal of eligible polyps using cold snare polypectomy technique
arm group label: Cold snare polypectomy
intervention type: Device
intervention name: Cold snare polypectomy
description: mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
arm group label: Cold snare polypectomy
intervention type: Device
intervention name: Cold biopsy polypectomy
description: standard- capacity forceps with narrow band imaging endoscopy
arm group label: cold biopsy polypectomy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bong Min Ko, MD
role: Principal Investigator
affiliation: SoonChunHyang University School of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Soo-kyung Park
investigator title: Clinical assistant professor
mesh term: Polyps