<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/NCT03797209</url>
  </required_header>
  <id_info>
    <org_study_id>E7121</org_study_id>
    <nct_id>NCT03797209</nct_id>
  </id_info>
  <brief_title>Hot AXIOS System Japan Post Market Survey</brief_title>
  <official_title>A Post Market Survey to Detect Information of Adverse Events and Device Malfunctions of AXIOS Stent and Electrocautery Enhanced Delivery System Under Real World Medical Condition in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Japan K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Japan K.K.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To detect information of Adverse Events and Device Malfunctions under real world medical&#xD;
      condition in Japan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Safety (Adverse Events and Device Malfunction)</measure>
    <time_frame>From implant procedure to 7 days after removal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Placement success</measure>
    <time_frame>During implant procedure</time_frame>
    <description>AXIOS stent is placed in an appropriate position using the delivery system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent retention</measure>
    <time_frame>From implant procedure to removal (a maximum of 60 days)</time_frame>
    <description>AXIOS stent stays at the position where it was implanted during the implant procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent lumen patency</measure>
    <time_frame>From implant procedure to removal (a maximum of 60 days)</time_frame>
    <description>The lumen of AXIOS stent is patent, and it can be used for drainage etc.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decreased cyst size</measure>
    <time_frame>From implant procedure to final observation (a maximum of 60 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Removal success</measure>
    <time_frame>Removal procedure (a maximum of 60 days after implant procedure)</time_frame>
    <description>AXIOS stent can be removed using standard endoscopic snares or forceps.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Pancreatic Pseudocyst Infection</condition>
  <condition>Pancreatic Pseudocyst</condition>
  <condition>Walled Off Necrosis Infection</condition>
  <condition>Walled Off Necrosis</condition>
  <arm_group>
    <arm_group_label>AXIOS Patient</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EUS-guided fistulization AXIOS</intervention_name>
    <description>By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.</description>
    <arm_group_label>AXIOS Patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient who received implant procedure using study device at Japanese site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who received implant procedure using study device at Japanese site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#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>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute-Shi</city>
        <state>Aichi</state>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya-Shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Nagoya-Shi</city>
        <state>Aichi</state>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital</name>
      <address>
        <city>Chiba-Shi</city>
        <state>Chiba</state>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kameda Medical Center</name>
      <address>
        <city>Kamogawa-Shi</city>
        <state>Chiba</state>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa-Shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Yachiyo Medical Center</name>
      <address>
        <city>Yachiyo-Shi</city>
        <state>Chiba</state>
        <zip>276-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka-Shi</city>
        <state>Fukuoka</state>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka-Shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teine Keijinkai Hospital</name>
      <address>
        <city>Sapporo-Shi</city>
        <state>Hokkaido</state>
        <zip>006-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe-Shi</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine Hospital</name>
      <address>
        <city>Nishinomiya-Shi</city>
        <state>Hyogo</state>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima-Shi</city>
        <state>Kagoshima</state>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura-Shi</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Sagamihara-Shi</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Rosai Hospital</name>
      <address>
        <city>Yokohama-Shi</city>
        <state>Kanagawa</state>
        <zip>222-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Yokohama-Shi</city>
        <state>Kanagawa</state>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Tsu-Shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-Shi</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Open Hospital</name>
      <address>
        <city>Sendai-Shi</city>
        <state>Miyagi</state>
        <zip>983-0824</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miyazaki Hospital</name>
      <address>
        <city>Miyazaki-Shi</city>
        <state>Miyazaki</state>
        <zip>889-1692</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical and Dental Hospital</name>
      <address>
        <city>Niigata-Shi</city>
        <state>Niigata</state>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawasaki Medical School General Medical Center</name>
      <address>
        <city>Okayama-Shi</city>
        <state>Okayama</state>
        <zip>700-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-Shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka-Shi</city>
        <state>Osaka</state>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osakasayama-Shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical College Hospital</name>
      <address>
        <city>Takatsuki-Shi</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Universtity International Medical Center</name>
      <address>
        <city>Hidaka-Shi</city>
        <state>Saitama</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center</name>
      <address>
        <city>Kawagoe-Shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Medical Center</name>
      <address>
        <city>Kitamoto-Shi</city>
        <state>Saitama</state>
        <zip>364-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <state>Shinjuku-Ku</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Shimotsuke-Shi</city>
        <state>Tochigi</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saiseikai Utsunomiya Hospital</name>
      <address>
        <city>Utsunomiya-Shi</city>
        <state>Tochigi</state>
        <zip>321-0974</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital</name>
      <address>
        <city>Bunkyo-Ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Ohashi Medical Center</name>
      <address>
        <city>Meguro-Ku</city>
        <state>Tokyo</state>
        <zip>153-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Minato-Ku</city>
        <state>Tokyo</state>
        <zip>105-8471</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka-Shi</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University Hospital</name>
      <address>
        <city>Wakayama-Shi</city>
        <state>Wakayama</state>
        <zip>641-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PPC</keyword>
  <keyword>WON</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT03797209
org study id: E7121
nct id: NCT03797209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To detect information of Adverse Events and Device Malfunctions under real world medical
      condition in Japan.
observational model: Cohort
time perspective: Prospective
measure: Safety (Adverse Events and Device Malfunction)
time frame: From implant procedure to 7 days after removal
measure: Placement success
time frame: During implant procedure
description: AXIOS stent is placed in an appropriate position using the delivery system.
measure: Stent retention
time frame: From implant procedure to removal (a maximum of 60 days)
description: AXIOS stent stays at the position where it was implanted during the implant procedure.
measure: Stent lumen patency
time frame: From implant procedure to removal (a maximum of 60 days)
description: The lumen of AXIOS stent is patent, and it can be used for drainage etc.
measure: Decreased cyst size
time frame: From implant procedure to final observation (a maximum of 60 days)
measure: Removal success
time frame: Removal procedure (a maximum of 60 days after implant procedure)
description: AXIOS stent can be removed using standard endoscopic snares or forceps.
arm group label: AXIOS Patient
intervention type: Device
intervention name: EUS-guided fistulization AXIOS
description: By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.
arm group label: AXIOS Patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Japan
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pancreatic Pseudocyst
mesh term: Necrosis
sharing ipd: No