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/NCT06031051</url>
    </required_header>
    <id_info>
      <org_study_id>CAPSUCOVID</org_study_id>
      <nct_id>NCT06031051</nct_id>
    </id_info>
    <brief_title>Capsule Endoscopy as an Alternative to Colonoscopy</brief_title>
    <acronym>CAPSUCOVID</acronym>
    <official_title>Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Clinic of Barcelona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medtronic</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital Clinic of Barcelona</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>
        This is a prospective, multicenter, interventional study assessing CE, in patients already&#xD;
        scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number&#xD;
        of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design Enrolled patients already scheduled for non-urgent colonoscopy according to&#xD;
        local practice will be offered to undergo an early CE; in case of negative proof they will&#xD;
        perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive&#xD;
        findings, requiring endoscopic treatment or intervention, colonoscopy will be performed&#xD;
        within 30 days from CE (early colonoscopy).&#xD;
  &#xD;
        Study population Patients who received the indication for colonoscopy as per clinical&#xD;
        practice and subsequently identified as non-urgent procedures, according to locally&#xD;
        established prioritization criteria&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 22, 2021</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>percentage of patients who could avoid colonoscopy</measure>
      <time_frame>6 months</time_frame>
      <description>To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CE diagnostic yield and adenoma detection rate (ADR)</measure>
      <time_frame>6 months</time_frame>
      <description>Number of adenoma detected by CE</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare CE and CC findings</measure>
      <time_frame>6 months</time_frame>
      <description>Compare findings between both techniques</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">704</enrollment>
    <condition>Colonic Disease</condition>
    <arm_group>
      <arm_group_label>Pillcam Crohn's Capsule Endoscopy and colonoscopy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pillcam Crohn's Capsule Endoscopy</intervention_name>
      <description>Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy</description>
      <arm_group_label>Pillcam Crohn's Capsule Endoscopy and colonoscopy</arm_group_label>
      <other_name>Pillcam</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Iron deficiency anaemia with or without a colonoscopy performed within the last 5&#xD;
               years&#xD;
  &#xD;
                 -  Rectal bleeding/haematochezia in patients &gt;50 years who have undergone a&#xD;
                    colonoscopy &lt;5 years ago or &lt;50 years with no risk factors for CRC&#xD;
  &#xD;
                 -  Chronic constipation/abdominal distension/abdominal pain/diarrhea&#xD;
  &#xD;
                 -  Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017)&#xD;
                    with no iFOBT performed&#xD;
  &#xD;
                 -  Recent change in bowel habits&#xD;
  &#xD;
                 -  Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary&#xD;
                    syndromes, CRC surgery, Inflammatory Bowel Disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Study following an episode of complicated acute diverticulitis or with an uncertain&#xD;
               diagnosis of acute diverticulitis&#xD;
  &#xD;
            -  Evaluation following fragmented resection (recurrence ruled out)&#xD;
  &#xD;
            -  Patients with a positive FIT&#xD;
  &#xD;
            -  Pregnancy or breast-feeding&#xD;
  &#xD;
            -  Any contraindication to Crohn's Capsule endoscopy such as known or suspected&#xD;
               gastrointestinal obstruction, strictures or fistulas, a previous altered Patency&#xD;
               capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other&#xD;
               implanted electromedical devices.&#xD;
  &#xD;
            -  Allergy or known contraindication to the medications and preparations agents used in&#xD;
               the procedure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>BEGOÑA GONZALEZ SUAREZ, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Clinic of Barcelona</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BEGOÑA GONZALEZ SUAREZ, MD, PhD</last_name>
      <phone>+34661334362</phone>
      <email>bgonzals@clinic.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Miguel Urpí Ferreruela, MD</last_name>
      <email>murpi@recerca.clinic.cat</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital universitario de Santa Cruz de Tenerife</name>
        <address>
          <city>Santa Cruz De Tenerife</city>
          <state>Canarias</state>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Zebenzuy Gimeno-García</last_name>
        <email>antozeben@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital clinic of barcelona</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>BEGOÑA GONZALEZ SUAREZ</last_name>
        <phone>+34661334362</phone>
        <email>bgonzals@clinic.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <zip>08041</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cristina Romero Mascarell, MD</last_name>
        <email>cromerom@santpau.cat</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Mutua de Terrassa</name>
        <address>
          <city>Terrassa</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Montserrat Aceituno Quintanilla</last_name>
        <email>maceituno@mutuaterrassa.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
      <investigator_full_name>Begoña González Suárez</investigator_full_name>
      <investigator_title>MD PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic Diseases</mesh_term>
    </condition_browse>
    <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/NCT06031051
  org study id: CAPSUCOVID
  nct id: NCT06031051
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, multicenter, interventional study assessing CE, in patients already
        scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number
        of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.
  Study design Enrolled patients already scheduled for non-urgent colonoscopy according to
        local practice will be offered to undergo an early CE; in case of negative proof they will
        perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive
        findings, requiring endoscopic treatment or intervention, colonoscopy will be performed
        within 30 days from CE (early colonoscopy).
  
        Study population Patients who received the indication for colonoscopy as per clinical
        practice and subsequently identified as non-urgent procedures, according to locally
        established prioritization criteria
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: percentage of patients who could avoid colonoscopy
  time frame: 6 months
  description: To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE
  measure: CE diagnostic yield and adenoma detection rate (ADR)
  time frame: 6 months
  description: Number of adenoma detected by CE
  measure: To compare CE and CC findings
  time frame: 6 months
  description: Compare findings between both techniques
  arm group label: Pillcam Crohn's Capsule Endoscopy and colonoscopy
  arm group type: Other
  description: All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy
  intervention type: Device
  intervention name: Pillcam Crohn's Capsule Endoscopy
  description: Patients with scheduled colonoscopy are invited to a previous exploration with capsule endoscopy
  arm group label: Pillcam Crohn's Capsule Endoscopy and colonoscopy
  other name: Pillcam
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: BEGOÑA GONZALEZ SUAREZ, MD PhD
  role: Principal Investigator
  affiliation: Hospital Clinic of Barcelona
  last name: BEGOÑA GONZALEZ SUAREZ, MD, PhD
  phone: +34661334362
  email: bgonzals@clinic.cat
  last name: Miguel Urpí Ferreruela, MD
  email: murpi@recerca.clinic.cat
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Clinic of Barcelona
  investigator full name: Begoña González Suárez
  investigator title: MD PhD
  mesh term: Colonic Diseases
  sharing ipd: No