<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/NCT02238665</url>
  </required_header>
  <id_info>
    <org_study_id>HN-0005</org_study_id>
    <nct_id>NCT02238665</nct_id>
  </id_info>
  <brief_title>CLE for Differential Diagnosis of IBD</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <brief_summary>
    <textblock>
      Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal&#xD;
      importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve&#xD;
      specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on&#xD;
      demand in vivo characterization of architectural and cellular details during endoscopy. Here,&#xD;
      we assessed the efficacy of CLE to differentiate between UC and CD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Number of participants with IBD</measure>
    <time_frame>4 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Ulcerative colitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Crohn's disease</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endomicroscopy</intervention_name>
    <arm_group_label>Crohn's disease</arm_group_label>
    <arm_group_label>Ulcerative colitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with well-established diagnosis of Crohn's disease and ulcerative&#xD;
        colitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  equal or above 18 years of age&#xD;
&#xD;
          -  ability to provide written informed consent&#xD;
&#xD;
          -  well-established diagnosis of CD or UC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of IBD reclassification in the last 3 years&#xD;
&#xD;
          -  Boston Bowel Preparation Scale score's &lt; 2 in at least one of the three broad regions&#xD;
             of the colon (i.e. rectum plus left side colon, transverse colon plus left and right&#xD;
             flexures, right colon)&#xD;
&#xD;
          -  inability to provide written informed consent&#xD;
&#xD;
          -  severe uncontrolled coagulopathy&#xD;
&#xD;
          -  impaired renal function&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  active gastrointestinal bleeding&#xD;
&#xD;
          -  known allergy to fluorescein&#xD;
&#xD;
          -  residence in institutions&#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>Helmut Neumann, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Erlangen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Helmut Neumann</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT02238665
org study id: HN-0005
nct id: NCT02238665
lead sponsor: 
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal
      importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve
      specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on
      demand in vivo characterization of architectural and cellular details during endoscopy. Here,
      we assessed the efficacy of CLE to differentiate between UC and CD.
time perspective: Prospective
measure: Number of participants with IBD
time frame: 4 years
arm group label: Ulcerative colitis
arm group label: Crohn's disease
intervention type: Device
intervention name: Endomicroscopy
arm group label: Crohn's disease
arm group label: Ulcerative colitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helmut Neumann, Professor
role: Principal Investigator
affiliation: University Hospital Erlangen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Helmut Neumann
investigator title: Professor
mesh term: Inflammatory Bowel Diseases