<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/NCT02199626</url>
  </required_header>
  <id_info>
    <org_study_id>CCE-2 in pediatric CD</org_study_id>
    <nct_id>NCT02199626</nct_id>
  </id_info>
  <brief_title>SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).</brief_title>
  <official_title>SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Policlinico Umberto I</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Policlinico Umberto I</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are&#xD;
      candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and&#xD;
      the second generation of colon capsule in comparison second generation of colon capsule&#xD;
      endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast&#xD;
      ultrasonography (SICUS) and endoscopy (upper and lower).&#xD;
&#xD;
      This study aims&#xD;
&#xD;
        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the&#xD;
           evaluation of pediatric Crohn's disease.&#xD;
&#xD;
        2. To evaluate the safety of CCE-2 in pediatric CD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 4</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>To evaluate and compare the accuracy of Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease.</measure>
    <time_frame>3 days</time_frame>
    <description>Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD.&#xD;
The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.</measure>
    <time_frame>two days</time_frame>
    <description>Number, type and severity of adverse events with second generation of Crohn's disease.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pediatric</condition>
  <condition>Colon Capsule Endoscopy</condition>
  <arm_group>
    <arm_group_label>CCE-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Second generation of Colon capsule endoscopy in pediatric Crohn's disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Second generation of colon capsule endoscopy (GIVEN IMAGING)</intervention_name>
    <arm_group_label>CCE-2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy&#xD;
        Volunteers: No&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        Subjects must meet one the following inclusion criteria to be eligible for enrollment into&#xD;
        this proposed study:&#xD;
&#xD;
          -  diagnosis of Crohn's Disease made at least 3 months before the enrolment;&#xD;
&#xD;
          -  subject was referred for endoscopic and imaging follow-up in Crohn's Disease&#xD;
&#xD;
          -  signed informed consent.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        The presence of any of the following will exclude a subject from study enrollment:&#xD;
&#xD;
          -  Subject has dysphagia&#xD;
&#xD;
          -  Subject has renal insufficiency&#xD;
&#xD;
          -  Subject is known structuring Crohn's Disease identified by magnetic resonance&#xD;
             enterography (MRE) or small intestine contrast ultrasonography (SICUS).&#xD;
&#xD;
          -  Subject has had prior abdominal surgery of the gastrointestinal tract other than&#xD;
             uncomplicated procedures that would be unlikely to lead to bowel obstruction based on&#xD;
             the magnetic resonance enterography findings and clinical judgment of the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Policlinico Umberto I</investigator_affiliation>
    <investigator_full_name>Giovanni Di Nardo</investigator_full_name>
    <investigator_title>SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT02199626
org study id: CCE-2 in pediatric CD
nct id: NCT02199626
lead sponsor: 
has dmc: No
This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are
      candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and
      the second generation of colon capsule in comparison second generation of colon capsule
      endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast
      ultrasonography (SICUS) and endoscopy (upper and lower).

      This study aims

        1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the
           evaluation of pediatric Crohn's disease.

        2. To evaluate the safety of CCE-2 in pediatric CD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To evaluate and compare the accuracy of Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease.
time frame: 3 days
description: Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD.
The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score).
measure: To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease.
time frame: two days
description: Number, type and severity of adverse events with second generation of Crohn's disease.
arm group label: CCE-2
arm group type: Experimental
description: Second generation of Colon capsule endoscopy in pediatric Crohn's disease
intervention type: Device
intervention name: Second generation of colon capsule endoscopy (GIVEN IMAGING)
arm group label: CCE-2
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Policlinico Umberto I
investigator full name: Giovanni Di Nardo
investigator title: SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
mesh term: Crohn Disease