<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/NCT03254498</url>
  </required_header>
  <id_info>
    <org_study_id>RD15/061</org_study_id>
    <nct_id>NCT03254498</nct_id>
  </id_info>
  <brief_title>Detection in Tandem Endocuff Cap Trial</brief_title>
  <acronym>DETECT</acronym>
  <official_title>Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London North West Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London North West Healthcare NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised back to back study comparing cap and Endocuff to detect adenomas during&#xD;
      colonoscopy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>
    <intervention_model_description>It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma miss rate</measure>
    <time_frame>1 day</time_frame>
    <description>Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean adenoma per procedure</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endocuff or cap exchange</measure>
    <time_frame>1 day</time_frame>
    <description>Number of times Cap or Endocuff are removed to complete the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ceacal intubation and withdrawal time</measure>
    <time_frame>1 day</time_frame>
    <description>Comparison of caecal intubation and withdrawal time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>miss rate of advanced polyps</measure>
    <time_frame>1 day</time_frame>
    <description>Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort score</measure>
    <time_frame>1 day</time_frame>
    <description>Comparison of patient comfort score between CAC and EAC</description>
  </secondary_outcome>
  <other_outcome>
    <measure>comparison of surveillance intervals</measure>
    <time_frame>Once histology is available usually takes 10-14 days</time_frame>
    <description>To compare any surveillance interval difference between CAC and EAC</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Colonic Neoplasms</condition>
  <condition>Adenomas Serrated</condition>
  <condition>Colo-rectal Cancer</condition>
  <condition>Colon Adenoma</condition>
  <arm_group>
    <arm_group_label>Endocuff assisted colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cap assisted colonoscopy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endocuff</intervention_name>
    <description>It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination</description>
    <arm_group_label>Endocuff assisted colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cap assisted colonoscopy (CAC)</intervention_name>
    <description>cap assisted colonoscopy (CAC)</description>
    <arm_group_label>Cap assisted colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years and over&#xD;
&#xD;
          2. Referral for surveillance, or diagnostic colonoscopy&#xD;
&#xD;
          3. Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Absolute contraindications to colonoscopy&#xD;
&#xD;
          2. Established or suspicion of large bowel obstruction or pseudo-obstruction&#xD;
&#xD;
          3. Known colon cancer or polyposis syndromes&#xD;
&#xD;
          4. Known colonic strictures&#xD;
&#xD;
          5. Known severe diverticular segment (that is likely to impede colonoscope passage)&#xD;
&#xD;
          6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis,&#xD;
             infective colitis)&#xD;
&#xD;
          7. Patients lacking capacity to give informed consent&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who&#xD;
             have not stopped this for the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian P Saunders, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Mark's Hospital, Northwest London Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NorthWest London Hospitals - NOrthwick park hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colonic adenoma</keyword>
  <keyword>serrated polyps</keyword>
  <keyword>caecal intubation time</keyword>
  <keyword>withdrawal time</keyword>
  <keyword>polyp miss rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03254498
org study id: RD15/061
nct id: NCT03254498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomised back to back study comparing cap and Endocuff to detect adenomas during
      colonoscopy
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Adenoma miss rate
time frame: 1 day
description: Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
measure: Mean adenoma per procedure
time frame: 1 day
description: Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
measure: Endocuff or cap exchange
time frame: 1 day
description: Number of times Cap or Endocuff are removed to complete the procedure
measure: Ceacal intubation and withdrawal time
time frame: 1 day
description: Comparison of caecal intubation and withdrawal time
measure: miss rate of advanced polyps
time frame: 1 day
description: Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
measure: Comfort score
time frame: 1 day
description: Comparison of patient comfort score between CAC and EAC
measure: comparison of surveillance intervals
time frame: Once histology is available usually takes 10-14 days
description: To compare any surveillance interval difference between CAC and EAC
arm group label: Endocuff assisted colonoscopy
arm group type: Active Comparator
description: Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
arm group label: Cap assisted colonoscopy
arm group type: Placebo Comparator
description: Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
intervention type: Device
intervention name: Endocuff
description: It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
arm group label: Endocuff assisted colonoscopy
intervention type: Device
intervention name: cap assisted colonoscopy (CAC)
description: cap assisted colonoscopy (CAC)
arm group label: Cap assisted colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Brian P Saunders, MD
role: Principal Investigator
affiliation: St Mark's Hospital, Northwest London Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Colonic Neoplasms
sharing ipd: No