<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/NCT03009383</url>
  </required_header>
  <id_info>
    <org_study_id>KNUH20161227</org_study_id>
    <nct_id>NCT03009383</nct_id>
  </id_info>
  <brief_title>A Bedside Portable Endoscopy for the Esophageal Foreign Body</brief_title>
  <official_title>Efficacy of a Bedside Portable Endoscopy on Identifying the Esophageal Foreign Body</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a bedside portable endoscopy is effective&#xD;
      in identifying the esophageal foreign body in the emergency room.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</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>Sensitivity, specificity, positive predictive value and negative predictive value of the bedside portable endoscopy to identify esophageal foreign body defined by comparison with conventional esophagogastroduodenoscopy as a gold standard method</measure>
    <time_frame>Within 1 hr after procedure</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Esophageal Foreign Body</condition>
  <arm_group>
    <arm_group_label>A bedside portable endoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>A bedside portable endoscopy</intervention_name>
    <arm_group_label>A bedside portable endoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who visit the emergency room due to apparent foreign body in esophagus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to insert a portable endoscopy through the nasal cavity&#xD;
&#xD;
          -  Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard&#xD;
             examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Choi JH, Choi JH, Lee YJ, Lee HK, Choi WY, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Comparison of a novel bedside portable endoscopy device with nasogastric aspiration for identifying upper gastrointestinal bleeding. World J Gastroenterol. 2014 Jul 7;20(25):8221-8. doi: 10.3748/wjg.v20.i25.8221.</citation>
    <PMID>25009396</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 31, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun Soo Kim, MD, PhD</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foreign Bodies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03009383
org study id: KNUH20161227
nct id: NCT03009383
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether a bedside portable endoscopy is effective
      in identifying the esophageal foreign body in the emergency room.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity, specificity, positive predictive value and negative predictive value of the bedside portable endoscopy to identify esophageal foreign body defined by comparison with conventional esophagogastroduodenoscopy as a gold standard method
time frame: Within 1 hr after procedure
arm group label: A bedside portable endoscopy
arm group type: Experimental
intervention type: Device
intervention name: A bedside portable endoscopy
arm group label: A bedside portable endoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Choi JH, Choi JH, Lee YJ, Lee HK, Choi WY, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Comparison of a novel bedside portable endoscopy device with nasogastric aspiration for identifying upper gastrointestinal bleeding. World J Gastroenterol. 2014 Jul 7;20(25):8221-8. doi: 10.3748/wjg.v20.i25.8221.
PMID: 25009396
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Eun Soo Kim, MD, PhD
investigator title: Associate professor
mesh term: Foreign Bodies
sharing ipd: No