xml: <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/NCT06008847</url>
    </required_header>
    <id_info>
      <org_study_id>RA545021</org_study_id>
      <nct_id>NCT06008847</nct_id>
    </id_info>
    <brief_title>Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study</brief_title>
    <acronym>CESCAIL</acronym>
    <official_title>Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Barcelona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospitals Coventry and Warwickshire 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>
        The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a&#xD;
        minimally-invasive imaging device, to improve efficiency and accuracy of the detection of&#xD;
        polyps, which are little outgrowths within the lining of the bowel.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be continuing to follow their standard care pathway, and there are no&#xD;
        additional requirements of the participants other than providing consent for their&#xD;
        pseudonymised capsule video and data to be used to test the AI system.&#xD;
  &#xD;
        The participant's final diagnosis will only be determined by the clinician's standard&#xD;
        analysis pathway and not influenced by the AI enabled analysis pathway. All data is&#xD;
        de-identified before a video is created and re-identified only once the standard final report&#xD;
        is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed&#xD;
        data is minimised.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 9, 2022</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 3, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity and specificity of polyp detection in AI enabled CCE reporting</measure>
      <time_frame>11 months</time_frame>
      <description>Sensitivity and specificity of polyp detection in AI enabled CCE reporting</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time taken to read video by clinicians and AI tool</measure>
      <time_frame>11 months</time_frame>
      <description>Time taken to read video by clinicians and AI tool</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">674</enrollment>
    <condition>Bowel Cancer</condition>
    <arm_group>
      <arm_group_label>Lower Gastrointestinal Symptoms</arm_group_label>
      <description>Participant aged over 18 with referred lower gastrointestinal symptoms</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Male or female, aged 18 and over&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 or over&#xD;
  &#xD;
            -  Patients who have been selected by overseeing clinician meeting NHS England criteria&#xD;
               to undergo colon capsule endoscopy as part of their standard of care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to provide consent to take part in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Hospitals Coventry and Warwickshire</name>
        <address>
          <city>Coventry</city>
          <zip>CV2 2DX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katie Tompkins</last_name>
        <phone>024 7696 27476</phone>
        <phone_ext>27476</phone_ext>
        <email>katie.tompkins@uhcw.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Ramesh Arasaradnam</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 7, 2022</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bowel</keyword>
    <keyword>cancer</keyword>
    <keyword>AI</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008847
  org study id: RA545021
  nct id: NCT06008847
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a
        minimally-invasive imaging device, to improve efficiency and accuracy of the detection of
        polyps, which are little outgrowths within the lining of the bowel.
  Participants will be continuing to follow their standard care pathway, and there are no
        additional requirements of the participants other than providing consent for their
        pseudonymised capsule video and data to be used to test the AI system.
  
        The participant's final diagnosis will only be determined by the clinician's standard
        analysis pathway and not influenced by the AI enabled analysis pathway. All data is
        de-identified before a video is created and re-identified only once the standard final report
        is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed
        data is minimised.
  observational model: Other
  time perspective: Prospective
  measure: Sensitivity and specificity of polyp detection in AI enabled CCE reporting
  time frame: 11 months
  description: Sensitivity and specificity of polyp detection in AI enabled CCE reporting
  measure: Time taken to read video by clinicians and AI tool
  time frame: 11 months
  description: Time taken to read video by clinicians and AI tool
  arm group label: Lower Gastrointestinal Symptoms
  description: Participant aged over 18 with referred lower gastrointestinal symptoms
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No