<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/NCT04423003</url>
  </required_header>
  <id_info>
    <org_study_id>242/2020BO2</org_study_id>
    <nct_id>NCT04423003</nct_id>
  </id_info>
  <brief_title>Endoscopic Interventions in Patients With COVID-19</brief_title>
  <official_title>Impact of the COVID-19 Pandemic on an Interdisciplinary Endoscopy Unit in a German &quot;Hotspot&quot; Area: a Single Center Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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 combined study including a descriptive part about the preparations for COVID-19 and&#xD;
      the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic&#xD;
      Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among&#xD;
      the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who&#xD;
      required endoscopic intervention.&#xD;
&#xD;
      Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the&#xD;
      processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3.&#xD;
      Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2&#xD;
      infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This article is intended to provide an overview of the impact of the COVID-19 pandemic on an&#xD;
      interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and&#xD;
      bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in&#xD;
      South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are&#xD;
      presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct&#xD;
      impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence&#xD;
      analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally,&#xD;
      to our knowledge for the first time, we conducted a prospective single center analysis of the&#xD;
      patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>death in time of observation</measure>
    <time_frame>01.March 2020 to 5. May 2020</time_frame>
    <description>death in time of observation</description>
  </primary_outcome>
  <enrollment type="Actual">10</enrollment>
  <condition>Change; Endoscopy, COVID-19</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic intervention</intervention_name>
    <description>All endoscopic interventions in COVID-19 positive tested patients were included</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        10 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with proven or suspected infections with SARS-CoV-2 infection, who required&#xD;
             endoscopic interventions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all other patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04423003
org study id: 242/2020BO2
nct id: NCT04423003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a combined study including a descriptive part about the preparations for COVID-19 and
      the impact of COVID-19 on the daily routine of the work in an Interdisciplinary Endoscopic
      Unit (IEU), and a point-prevalence analysis for possible positive SARS-CoV-2 carriers among
      the staff of the IEU, and finally a prospective analysis of SARS-CoV-2 positive patients who
      required endoscopic intervention.

      Results are presented in the captures: 1. SARS-CoV-2-pandemic related restructuring of the
      processes in the IEU, 2. SARS-CoV-2-pandemic related impact on the staff of the IEU, and 3.
      Analysis of endoscopic interventions in patients with confirmed or suspected SARS-CoV-2
      infection.
This article is intended to provide an overview of the impact of the COVID-19 pandemic on an
      interdisciplinary endoscopy unit (IEU, gastroenterological endoscopy, surgical endoscopy, and
      bronchoscopy) at the University Hospital Tübingen, a center for tertiary care in
      South-western Germany. First, preparations for COVID-19 pandemic with respect to the IEU are
      presented, and compared with those of other endoscopy units (7, 8). Additionally, the direct
      impact of SARS-CoV-2 on the staff of the IEU will be shown, together with a point-prevalence
      analysis of SARS-CoV-2 of the staff at the end of the SARS-CoV-2 wave in Tübingen. Finally,
      to our knowledge for the first time, we conducted a prospective single center analysis of the
      patients infected with SARS-CoV-2, which required a diagnostic or therapeutic endoscopic
      intervention.
observational model: Cohort
time perspective: Prospective
measure: death in time of observation
time frame: 01.March 2020 to 5. May 2020
description: death in time of observation
intervention type: Procedure
intervention name: Endoscopic intervention
description: All endoscopic interventions in COVID-19 positive tested patients were included
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided