<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/NCT03016962</url>
  </required_header>
  <id_info>
    <org_study_id>Cap</org_study_id>
    <nct_id>NCT03016962</nct_id>
  </id_info>
  <brief_title>Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery</brief_title>
  <official_title>Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The potential benefit of using the cap is that it helps in luminal orientation at bends by&#xD;
      keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients&#xD;
      with a history of abdominal surgery is considered to be difficult due to adhesion-related&#xD;
      bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in&#xD;
      patients with prior abdominal surgery. The investigators designed a randomized, controlled&#xD;
      trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The potential benefit of using the cap is that it helps in luminal orientation at bends by&#xD;
      keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in&#xD;
      negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can&#xD;
      be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy.&#xD;
      Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due&#xD;
      to adhesion-related bowel angulations. There were few study evaluating usefulness of&#xD;
      cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed&#xD;
      a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in&#xD;
      patients with prior abdominal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insertion time</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient discomfort</measure>
    <time_frame>Day 1</time_frame>
    <description>10-point visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall technical ease</measure>
    <time_frame>Day 1</time_frame>
    <description>10-point visual analog scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1046</enrollment>
  <condition>Insertion Time</condition>
  <arm_group>
    <arm_group_label>Cap-assisted colonoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cap-assisted colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cap-assisted colonoscopy</intervention_name>
    <description>cap-assisted colonoscopy</description>
    <arm_group_label>Cap-assisted colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard colonoscopy</intervention_name>
    <description>Standard colonoscopy</description>
    <arm_group_label>Standard colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with history of abdominal or pelvic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous colorectal resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Jeong-Seon Ji</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03016962
org study id: Cap
nct id: NCT03016962
lead sponsor: 
has dmc: Yes
The potential benefit of using the cap is that it helps in luminal orientation at bends by
      keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients
      with a history of abdominal surgery is considered to be difficult due to adhesion-related
      bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in
      patients with prior abdominal surgery. The investigators designed a randomized, controlled
      trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal
      surgery.
The potential benefit of using the cap is that it helps in luminal orientation at bends by
      keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in
      negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can
      be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy.
      Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due
      to adhesion-related bowel angulations. There were few study evaluating usefulness of
      cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed
      a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in
      patients with prior abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Insertion time
time frame: Day 1
measure: Patient discomfort
time frame: Day 1
description: 10-point visual analog scale
measure: Overall technical ease
time frame: Day 1
description: 10-point visual analog scale
arm group label: Cap-assisted colonoscopy
arm group type: Experimental
description: cap-assisted colonoscopy
arm group label: Standard colonoscopy
arm group type: Active Comparator
description: Standard colonoscopy
intervention type: Device
intervention name: cap-assisted colonoscopy
description: cap-assisted colonoscopy
arm group label: Cap-assisted colonoscopy
intervention type: Device
intervention name: Standard colonoscopy
description: Standard colonoscopy
arm group label: Standard colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Jeong-Seon Ji
investigator title: Dr
sharing ipd: No