xml: <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/NCT06017102</url>
    </required_header>
    <id_info>
      <org_study_id>202210059DIPA</org_study_id>
      <nct_id>NCT06017102</nct_id>
    </id_info>
    <brief_title>Wired Magnetically Assisted Capsule Endoscopy and Esophageal Varices</brief_title>
    <official_title>Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Insight Medical Solutions</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the safeness and effectiveness of traditional&#xD;
        esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in&#xD;
        the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  Subjects who do wired magnetically assisted capsule endoscopy do not need to open the&#xD;
             mouths during the process, this study also want to know whether wired magnetically&#xD;
             assisted capsule endoscopy can reduce the generation of droplets.&#xD;
  &#xD;
          -  Diagnostic accuracy between traditional esophagogastroduodenoscope and wired&#xD;
             magnetically assisted capsule endoscopy in biliary atresia patients with esophageal&#xD;
             varices.&#xD;
  &#xD;
        Participants will do either traditional esophagogastroduodenoscope or wired magnetically&#xD;
        assisted capsule endoscopy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Aerosol-generating amount</measure>
      <time_frame>1-2 days</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Esophageal Varices</condition>
    <arm_group>
      <arm_group_label>wired magnetic assisted capsule endoscopy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>esophagogastroduodenoscopy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>wired magnetic assisted capsule endoscopy</intervention_name>
      <description>once</description>
      <arm_group_label>wired magnetic assisted capsule endoscopy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>esophagogastroduodenoscopy</intervention_name>
      <description>once</description>
      <arm_group_label>esophagogastroduodenoscopy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biliary atresia patients &gt; 6 years old&#xD;
  &#xD;
            -  Vital signs are stable&#xD;
  &#xD;
            -  Without acute gastrointestinal bleeding&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with metal implants, metal stent, artificial joints, bone plates, and bone&#xD;
               screw&#xD;
  &#xD;
            -  Patients with electronic devices, such as pacemakers, cochlear implants, or other&#xD;
               implanted electronic medical devices&#xD;
  &#xD;
            -  Throat or esophageal obstruction leading to dysphagia patients&#xD;
  &#xD;
            -  Consciousness disturbance patients unable to swallow&#xD;
  &#xD;
            -  Patients with acute upper gastrointestinal bleeding&#xD;
  &#xD;
            -  Patients with platelet lower than 40K or PT INR &gt; 1.5&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jia-Feng Wu, PhD</last_name>
      <phone>+886 23123456</phone>
      <phone_ext>271718</phone_ext>
      <email>wjf@ntu.edu.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fang-Yu Tseng</last_name>
      <phone>+886 23123456</phone>
      <phone_ext>271737</phone_ext>
      <email>vanny7306@yahoo.com.tw</email>
    </overall_contact_backup>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>upper endoscopy</keyword>
    <keyword>biliary atresia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal and Gastric Varices</mesh_term>
      <mesh_term>Biliary Atresia</mesh_term>
      <mesh_term>Varicose Veins</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017102
  org study id: 202210059DIPA
  nct id: NCT06017102
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the safeness and effectiveness of traditional
        esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in
        the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it
        aims to answer are:
  
          -  Subjects who do wired magnetically assisted capsule endoscopy do not need to open the
             mouths during the process, this study also want to know whether wired magnetically
             assisted capsule endoscopy can reduce the generation of droplets.
  
          -  Diagnostic accuracy between traditional esophagogastroduodenoscope and wired
             magnetically assisted capsule endoscopy in biliary atresia patients with esophageal
             varices.
  
        Participants will do either traditional esophagogastroduodenoscope or wired magnetically
        assisted capsule endoscopy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Aerosol-generating amount
  time frame: 1-2 days
  arm group label: wired magnetic assisted capsule endoscopy
  arm group type: Experimental
  arm group label: esophagogastroduodenoscopy
  arm group type: Other
  intervention type: Device
  intervention name: wired magnetic assisted capsule endoscopy
  description: once
  arm group label: wired magnetic assisted capsule endoscopy
  intervention type: Device
  intervention name: esophagogastroduodenoscopy
  description: once
  arm group label: esophagogastroduodenoscopy
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jia-Feng Wu, PhD
  phone: +886 23123456
  phone ext: 271718
  email: wjf@ntu.edu.tw
  last name: Fang-Yu Tseng
  phone: +886 23123456
  phone ext: 271737
  email: vanny7306@yahoo.com.tw
  responsible party type: Sponsor
  mesh term: Esophageal and Gastric Varices
  mesh term: Biliary Atresia
  mesh term: Varicose Veins