<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/NCT04415463</url>
  </required_header>
  <id_info>
    <org_study_id>NL73180.091.20</org_study_id>
    <nct_id>NCT04415463</nct_id>
  </id_info>
  <brief_title>Esophageal Multisegmented FCSEMS for Malignant Strictures</brief_title>
  <acronym>EATERS</acronym>
  <official_title>EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To assess the safety and feasibility of the implementation of the esophageal&#xD;
      multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of&#xD;
      patients with malignant dysphagia.&#xD;
&#xD;
      Study design: Prospective observational nonrandomized clinical study.&#xD;
&#xD;
      Study population: A total of 30 patients with malignant dysphagia will be included. Sample&#xD;
      size calculation does not apply for this type of study.&#xD;
&#xD;
      Intervention: All patients will be treated with the esophageal multisegmented fully covered&#xD;
      SEMS.&#xD;
&#xD;
      Primary end points:&#xD;
&#xD;
        -  Safety: complications and adverse events during follow-up with special attention to&#xD;
           stent migration rates;&#xD;
&#xD;
        -  Efficacy: technical success of stent placement.&#xD;
&#xD;
      Secondary end points:&#xD;
&#xD;
        -  Recurrent dysphagia including its cause;&#xD;
&#xD;
        -  Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at&#xD;
           baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6&#xD;
           months follow-up);&#xD;
&#xD;
        -  Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation&#xD;
           during follow-up);&#xD;
&#xD;
        -  Pain related to esophageal stent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Safety concerns&#xD;
  </why_stopped>
  <start_date type="Actual">March 3, 2021</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse events during follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Technical success of stent placement</measure>
    <time_frame>1 day</time_frame>
    <description>Technical success of stent placement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrent dysphagia</measure>
    <time_frame>6 months</time_frame>
    <description>Ogilvie dysphagia score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>6 months</time_frame>
    <description>WHO performance score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue ingrowth or overgrowth</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain related to esophageal stent</measure>
    <time_frame>6 months</time_frame>
    <description>Measured using the Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Oesophageal Cancer</condition>
  <condition>Esophageal Stent Stenosis</condition>
  <arm_group>
    <arm_group_label>FC-SEMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement of multisegmented fully covered self-expandable metal stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multisegmented fully covered self-expandable metal stent</intervention_name>
    <description>Esophageal FC-SEMS</description>
    <arm_group_label>FC-SEMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients presenting with dysphagia due to a non-operable malignant obstruction of the&#xD;
             esophagus or esophagogastric junction including extrinsic malignant compression and&#xD;
             recurrence in post-esophagectomy patients;&#xD;
&#xD;
          -  Requiring treatment for dysphagia (Ogilvie score of 2-41);&#xD;
&#xD;
          -  Life expectancy of less than 12 months.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Stenosis after laryngectomy;&#xD;
&#xD;
          -  Distance between the upper edge of the stent less than 2 cm from the upper esophageal&#xD;
             sphincter;&#xD;
&#xD;
          -  Esophageal fistula;&#xD;
&#xD;
          -  Tumor length of more than 14 cm;&#xD;
&#xD;
          -  Previous stent placement for the same condition;&#xD;
&#xD;
          -  Inappropriate cultural level and understanding of the study;&#xD;
&#xD;
          -  Coagulopathy;&#xD;
&#xD;
          -  Patients with eosinophilic esophagitis or an esophageal motility disorder;&#xD;
&#xD;
          -  Nickel titanium (Nitinol) allergy.&#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>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04415463
org study id: NL73180.091.20
nct id: NCT04415463
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Objective: To assess the safety and feasibility of the implementation of the esophageal
      multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of
      patients with malignant dysphagia.

      Study design: Prospective observational nonrandomized clinical study.

      Study population: A total of 30 patients with malignant dysphagia will be included. Sample
      size calculation does not apply for this type of study.

      Intervention: All patients will be treated with the esophageal multisegmented fully covered
      SEMS.

      Primary end points:

        -  Safety: complications and adverse events during follow-up with special attention to
           stent migration rates;

        -  Efficacy: technical success of stent placement.

      Secondary end points:

        -  Recurrent dysphagia including its cause;

        -  Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at
           baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6
           months follow-up);

        -  Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation
           during follow-up);

        -  Pain related to esophageal stent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
time frame: 6 months
description: Adverse events during follow-up
measure: Technical success of stent placement
time frame: 1 day
description: Technical success of stent placement
measure: Recurrent dysphagia
time frame: 6 months
description: Ogilvie dysphagia score
measure: Functional outcome
time frame: 6 months
description: WHO performance score
measure: Tissue ingrowth or overgrowth
time frame: 6 months
measure: Pain related to esophageal stent
time frame: 6 months
description: Measured using the Visual Analogue Scale (VAS)
arm group label: FC-SEMS
arm group type: Experimental
description: Placement of multisegmented fully covered self-expandable metal stent
intervention type: Device
intervention name: Multisegmented fully covered self-expandable metal stent
description: Esophageal FC-SEMS
arm group label: FC-SEMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No