<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/NCT03269903</url>
  </required_header>
  <id_info>
    <org_study_id>NL.59951.091.16</org_study_id>
    <nct_id>NCT03269903</nct_id>
  </id_info>
  <brief_title>TTS Esophageal HILZO Stent: A Safety and Feasibility Study</brief_title>
  <acronym>HILZO</acronym>
  <official_title>TTS Esophageal HILZO Covered Self-expandable Metal Stent for Palliation of Malignant Dysphagia: A Safety and Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kebomed B.V.</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>
      A multicenter non-randomized prospective clinical study assessing the safety and feasibility&#xD;
      of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for&#xD;
      palliation of malignant dysphagia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to evaluate the safety and efficacy of placement of the&#xD;
      esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant&#xD;
      obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or&#xD;
      recurrent malignant dysphagia after esophagectomy.&#xD;
&#xD;
      Other (secondary) objects are to assess the effect of the stent on the presence of&#xD;
      hyperplastic reaction after implantation, the functional complications and survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>
    <intervention_model_description>Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment associated adverse events during follow-up (safety)</measure>
    <time_frame>1 year</time_frame>
    <description>Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location</measure>
    <time_frame>1 day</time_frame>
    <description>Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement</measure>
    <time_frame>1 day</time_frame>
    <description>Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)</measure>
    <time_frame>6 months</time_frame>
    <description>Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)</measure>
    <time_frame>6 months</time_frame>
    <description>Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophagus Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with malignant dysphagia treated with the HILZO stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HILZO esophageal stent</intervention_name>
    <description>A fully covered esophageal self-expandable metal stent for malignant dysphagia</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-operable malignant obstruction of the esophagus or esophagogastric junction,&#xD;
             extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy.&#xD;
             A tumor is considered inoperable if the patient has local tumor infiltration in the&#xD;
             surrounding organs, distant metastases or a poor general health due to serious&#xD;
             concomitant disease. OR&#xD;
&#xD;
          -  Recurrent dysphagia after prior radiation with curative or palliative intent for&#xD;
             esophageal or gastric cardia cancer.&#xD;
&#xD;
          -  Requiring treatment for dysphagia (dysphagia score of ≥ 2, according to Ogilvie2)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inappropriate cultural level and understanding of the study.&#xD;
&#xD;
          -  Simultaneous participation in another clinical study&#xD;
&#xD;
          -  Life expectancy of less than 12 months&#xD;
&#xD;
          -  Stenosis after laryngectomy, or if the distance between the upper edge of the stent is&#xD;
             less than 2 cm from the upper esophageal sphincter&#xD;
&#xD;
          -  Tumor length of more than 12cm&#xD;
&#xD;
          -  Previous stent placement for the same condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Siersema, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bram Vermeulen, Drs.</last_name>
    <phone>0031611079557</phone>
    <email>bram.vermeulen@radboudumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bram Vermeulen, Drs.</last_name>
      <phone>0031611079557</phone>
      <email>bram.vermeulen@radboudumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>May 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</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>Esophageal Neoplasms</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/NCT03269903
org study id: NL.59951.091.16
nct id: NCT03269903
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A multicenter non-randomized prospective clinical study assessing the safety and feasibility
      of the esophageal through-the-scope HILZO Covered self-expandable metal stent placement for
      palliation of malignant dysphagia
The main objective of this study is to evaluate the safety and efficacy of placement of the
      esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant
      obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or
      recurrent malignant dysphagia after esophagectomy.

      Other (secondary) objects are to assess the effect of the stent on the presence of
      hyperplastic reaction after implantation, the functional complications and survival.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Multicenter non-randomized prospective clinical study in 30 patients with malignant dysphagia
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of treatment associated adverse events during follow-up (safety)
time frame: 1 year
description: Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
measure: Through-the-scope stent placement (feasibility): (1) ease of deployment at intended esophageal location
time frame: 1 day
description: Technical success is defined as ease of through-the-scope deployment and placement of the stent at the required esophageal location.
measure: Through-the-scope stent placement (feasibility): incidence of device related adverse device events at moment of stent placement
time frame: 1 day
description: Device related adverse events are defined as all adverse events that take place during the through-the-scope stent placement. The incidence of the device related adverse events will be recorded.
measure: Dysphagia, measured with the Ogilvie Dysphagia score (functional outcome)
time frame: 6 months
description: Ogilvie dysphagia score measured at: baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up.
measure: Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale (functional outcome)
time frame: 6 months
description: Retrosternal pain related to esophageal stent, measured with the Visual Analog Scale. Measurements will take place at 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up
arm group label: Patients
arm group type: Experimental
description: Patients with malignant dysphagia treated with the HILZO stent
intervention type: Device
intervention name: HILZO esophageal stent
description: A fully covered esophageal self-expandable metal stent for malignant dysphagia
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Siersema, professor
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: Bram Vermeulen, Drs.
phone: 0031611079557
email: bram.vermeulen@radboudumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: No