<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/NCT03808272</url>
  </required_header>
  <id_info>
    <org_study_id>E7148</org_study_id>
    <nct_id>NCT03808272</nct_id>
  </id_info>
  <brief_title>AXIOS CHINA (E7148)</brief_title>
  <official_title>A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</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>
      To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced&#xD;
      Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off&#xD;
      necrosis in Chinese population, to support the regulatory approval by CFDA&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 24, 2020</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>Technical success rate</measure>
    <time_frame>28± 7 days post stent placement</time_frame>
    <description>defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>28± 7 days post stent placement</time_frame>
    <description>defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Pancreatic Pseudocyst and Walled-off Necrosis</condition>
  <arm_group>
    <arm_group_label>HOT AXIOS Stent and Electrocautery- Enhanced Delivery System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HOT AXIOS Stent and Electrocautery- Enhanced Delivery System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HOT AXIOS Stent and Electrocautery- Enhanced Delivery System</intervention_name>
    <description>The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.</description>
    <arm_group_label>HOT AXIOS Stent and Electrocautery- Enhanced Delivery System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 75 years old(including 18 and 75 years old)&#xD;
&#xD;
          2. Eligible for endoscopic intervention&#xD;
&#xD;
          3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage&#xD;
&#xD;
          4. Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and&#xD;
             walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are&#xD;
             adherent to the gastric or bowel wall&#xD;
&#xD;
          5. Patient understands the study requirements and the treatment procedures and provides&#xD;
             written Informed Consent.&#xD;
&#xD;
          6. Patient is willing to comply with all specified follow-up evaluations, including&#xD;
             willingness to undergo a pre/post CT imaging study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &lt;18 or &gt;75 years of age&#xD;
&#xD;
          2. pseudocysts or walled-off necrosis which require nasocystic drainage,or&lt;6cm in maximum&#xD;
             diameter, or walled-off necrosis &lt; 70% fluid content&#xD;
&#xD;
          3. The fluid collection to be drained is an immature pseudocyst&#xD;
&#xD;
          4. The fluid collection to be drained is a cystic neoplasm&#xD;
&#xD;
          5. The fluid collection to be drained is a pseudoaneurysm&#xD;
&#xD;
          6. The fluid collection to be drained is a duplication cyst&#xD;
&#xD;
          7. The fluid collection to be drained is a non-inflammatory fluid collection&#xD;
&#xD;
          8. There is more than one pseudocyst requiring drainage&#xD;
&#xD;
          9. Abnormal coagulation: INR &gt; 1.5 and not correctable presence of a bleeding disorder;&#xD;
             platelets &lt; 50,000/mm3&#xD;
&#xD;
         10. Altered anatomy that precludes the physician's ability to deliver the stent (decision&#xD;
             on a case by case basis).&#xD;
&#xD;
         11. Intervening gastric varices or vessels within a one centimeter radius of the needle&#xD;
             (visible using endoscopy or endoscopic ultrasound)&#xD;
&#xD;
         12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium),&#xD;
             silicone or any other materials contacting the patient.&#xD;
&#xD;
         13. Female of childbearing potential with a positive pregnancy test prior to the procedure&#xD;
             or intends to become pregnant during the study.&#xD;
&#xD;
         14. Currently participating in another investigational drug of device study that has not&#xD;
             completed the primary endpoint or that clinically interferes with the endpoints of&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhiyu Zeng</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</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>Pancreatic Pseudocyst</mesh_term>
    <mesh_term>Necrosis</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/NCT03808272
org study id: E7148
nct id: NCT03808272
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced
      Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off
      necrosis in Chinese population, to support the regulatory approval by CFDA
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success rate
time frame: 28± 7 days post stent placement
description: defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.
measure: Clinical success rate
time frame: 28± 7 days post stent placement
description: defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis
arm group label: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
arm group type: Experimental
description: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
intervention type: Device
intervention name: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
description: The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.
arm group label: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhiyu Zeng
role: Study Chair
affiliation: Boston Scientific Corporation
facility: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Pseudocyst
mesh term: Necrosis
sharing ipd: No