<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/NCT02184754</url>
  </required_header>
  <id_info>
    <org_study_id>12-2014</org_study_id>
    <nct_id>NCT02184754</nct_id>
  </id_info>
  <brief_title>Magnetic Endoscope Imaging in Single-balloon-enteroscopy</brief_title>
  <acronym>Magenta</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope&#xD;
      navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in&#xD;
      which scope navigation is particularly important. The MEI will be compared with x-ray which&#xD;
      is still the current gold standard for scope navigation in small bowel enteroscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of concordance of MEI- and x-ray-images</measure>
    <time_frame>5 days</time_frame>
    <description>Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Magnetic Endoscope Imaging in Single-balloon-enteroscopy</condition>
  <arm_group>
    <arm_group_label>MEI</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic endoscope imaging (MEI)</intervention_name>
    <arm_group_label>MEI</arm_group_label>
    <other_name>Olympus MAJ-Y0158</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        endoscopy unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for enteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for enteroscopy&#xD;
&#xD;
          -  patients with cardiac pacemaker or defibrillator&#xD;
&#xD;
          -  pregnancy&#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>Klinikum rechts der Isar</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>January 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>January 28, 2015</last_update_submitted>
  <last_update_submitted_qc>January 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic endoscope imaging</keyword>
  <keyword>single-balloon-enteroscopy</keyword>
  <!-- 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/NCT02184754
org study id: 12-2014
nct id: NCT02184754
lead sponsor: 
has dmc: No
Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope
      navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in
      which scope navigation is particularly important. The MEI will be compared with x-ray which
      is still the current gold standard for scope navigation in small bowel enteroscopy.
observational model: Cohort
time perspective: Prospective
measure: Number of concordance of MEI- and x-ray-images
time frame: 5 days
description: Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance
arm group label: MEI
intervention type: Procedure
intervention name: Magnetic endoscope imaging (MEI)
arm group label: MEI
other name: Olympus MAJ-Y0158
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor