<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/NCT03767881</url>
  </required_header>
  <id_info>
    <org_study_id>E7108</org_study_id>
    <nct_id>NCT03767881</nct_id>
  </id_info>
  <brief_title>AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE</brief_title>
  <official_title>A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced&#xD;
      Delivery System in the management of symptoms of acute cholecystitis as an alternative to&#xD;
      percutaneous gallbladder drainage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients&#xD;
      will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will&#xD;
      receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2019</start_date>
  <completion_date type="Actual">December 2, 2021</completion_date>
  <primary_completion_date type="Actual">December 2, 2021</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>Number of Days to Resolution of Acute Cholecystitis</measure>
    <time_frame>Up to 15 weeks</time_frame>
    <description>Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Re-interventions</measure>
    <time_frame>Through study completion, Up to 15 weeks</time_frame>
    <description>Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stent Patency</measure>
    <time_frame>Stent placement through stent removal, approximately 60 days</time_frame>
    <description>Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Successful Technical Stent Placement.</measure>
    <time_frame>Intraoperative (stent placement)</time_frame>
    <description>Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Successful Technical Stent Removal.</measure>
    <time_frame>Intraoperative (stent removal)</time_frame>
    <description>Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events</description>
  </other_outcome>
  <other_outcome>
    <measure>Acute Cholecystitis Recurrence</measure>
    <time_frame>Through study completion, up to 15 weeks</time_frame>
    <description>Recurrence of acute cholecystitis and its management post AXIOS stent removal</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Cumulative Hospital and ICU Days</measure>
    <time_frame>Through study completion, up to 15 weeks</time_frame>
    <description>Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cholecystitis, Acute</condition>
  <arm_group>
    <arm_group_label>AXIOS(TM) Stent and Electrocautery Enhanced Delivery System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AXIOS(TM) Stent and Electrocautery Enhanced Delivery System</intervention_name>
    <description>Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.</description>
    <arm_group_label>AXIOS(TM) Stent and Electrocautery Enhanced Delivery System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient requiring intervention for the management of symptoms associated with acute&#xD;
             cholecystitis&#xD;
&#xD;
          2. Patients referred for percutaneous drainage of the gallbladder who are not surgical&#xD;
             candidates because of advanced age, anesthetic risk, significant co-morbidities and/or&#xD;
             overall health&#xD;
&#xD;
          3. Eligible for endoscopic intervention&#xD;
&#xD;
          4. Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:&#xD;
&#xD;
               -  AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient&#xD;
                  with mild local inflammatory changes and without organ dysfunction. Criteria for&#xD;
                  grade II or III not met.&#xD;
&#xD;
               -  AC Grade II (moderate) defined by any one of the following characteristics&#xD;
&#xD;
                    -  Leukocytosis (&gt;18,000 cells per mm3)&#xD;
&#xD;
                    -  Palpable, tender mass in right upper quadrant&#xD;
&#xD;
                    -  Symptom duration &gt;72 hours&#xD;
&#xD;
                    -  Marked local inflammation (gangrenous or emphysematous cholecystitis,&#xD;
                       pericholecystic or hepatic abscess, biliary peritonitis)&#xD;
&#xD;
          5. Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent&#xD;
             deployment and complete flange expansion&#xD;
&#xD;
          6. 18 years of age or older&#xD;
&#xD;
          7. Willing and able to comply with the study procedures and patient or legally authorized&#xD;
             representative (LAR) must provide written informed consent form (ICF) to participate&#xD;
             in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of&#xD;
             the following systems:&#xD;
&#xD;
               -  Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine&#xD;
                  or any dose of norepinephrine&#xD;
&#xD;
               -  Neurologic - decreased level of consciousness&#xD;
&#xD;
               -  Respiratory - PaO2/FiO2 &lt;300&#xD;
&#xD;
               -  Renal - Oliguria and Creatinine &gt;2.0 mg/dl (&gt;177 μmol/liter)&#xD;
&#xD;
               -  Hepatic - International normalized ratio &gt;1.5&#xD;
&#xD;
               -  Hematologic - Platelet count &lt;100,000/mm3&#xD;
&#xD;
          2. Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic&#xD;
             gallbladder&#xD;
&#xD;
          3. Hepatic abscess&#xD;
&#xD;
          4. Ascites&#xD;
&#xD;
          5. Patients with abnormal coagulation or who require ongoing complete anticoagulation&#xD;
&#xD;
          6. Bleeding diathesis&#xD;
&#xD;
          7. History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)&#xD;
&#xD;
          8. Patients with a current percutaneous drainage&#xD;
&#xD;
          9. Patients with a history of percutaneous gallbladder drainage without AC free period&#xD;
             following percutaneous drainage removal&#xD;
&#xD;
         10. Distance between gallbladder wall and duodenal or gastric wall &gt; 1cm by US&#xD;
             (ultrasound) at the time of drainage&#xD;
&#xD;
         11. Patients with intervening gastric varices or vessels within a one centimeter radius of&#xD;
             the device insertion location&#xD;
&#xD;
         12. Patients that have allergies or are sensitive to any of the device materials&#xD;
&#xD;
         13. Patients with contraindications to use of electrical devices&#xD;
&#xD;
         14. Pregnancy&#xD;
&#xD;
         15. Prisoners and other vulnerable populations&#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>Shayan Irani, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Mason Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Medical Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>B-3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>November 28, 2022</results_first_submitted>
  <results_first_submitted_qc>January 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2023</results_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AXIOS</keyword>
  <keyword>Acute Cholecystitis</keyword>
  <keyword>Percutaneous Gallbladder Drainage</keyword>
  <keyword>Cholecystitis</keyword>
  <keyword>Gallbladder Drainage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Acalculous Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03767881/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03767881/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
          <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
          <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.2" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.4" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.6" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Days to Resolution of Acute Cholecystitis</title>
        <description>Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.</description>
        <time_frame>Up to 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS(TM) Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.&#xD;
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days to Resolution of Acute Cholecystitis</title>
          <description>Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.30" spread="14.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.5</param_value>
            <ci_percent>97.8</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>10.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Re-interventions</title>
        <description>Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.</description>
        <time_frame>Through study completion, Up to 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Re-interventions</title>
          <description>Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.</non_inferiority_desc>
            <param_type>Performance Goal</param_type>
            <param_value>16.7</param_value>
            <ci_percent>99.7</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>42.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stent Patency</title>
        <description>Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen</description>
        <time_frame>Stent placement through stent removal, approximately 60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Patency</title>
          <description>Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Successful Technical Stent Placement.</title>
        <description>Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent</description>
        <time_frame>Intraoperative (stent placement)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Technical Stent Placement.</title>
          <description>Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Successful Technical Stent Removal.</title>
        <description>Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events</description>
        <time_frame>Intraoperative (stent removal)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Technical Stent Removal.</title>
          <description>Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Acute Cholecystitis Recurrence</title>
        <description>Recurrence of acute cholecystitis and its management post AXIOS stent removal</description>
        <time_frame>Through study completion, up to 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Cholecystitis Recurrence</title>
          <description>Recurrence of acute cholecystitis and its management post AXIOS stent removal</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Cumulative Hospital and ICU Days</title>
        <description>Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis</description>
        <time_frame>Through study completion, up to 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
            <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cumulative Hospital and ICU Days</title>
          <description>Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.30" spread="7.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AXIOS Stent and Electrocautery Enhanced Delivery System</title>
          <description>Patients will receive the AXIOS stent for the treatment of&#xD;
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Traumatic liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Troponin T increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (24.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Evelyne Ho, Clinical Project Manager</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>1-978-483-8856</phone>
      <email>Evelyne.ho@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03767881
org study id: E7108
nct id: NCT03767881
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced
      Delivery System in the management of symptoms of acute cholecystitis as an alternative to
      percutaneous gallbladder drainage.
This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients
      will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will
      receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Days to Resolution of Acute Cholecystitis
time frame: Up to 15 weeks
description: Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
measure: Rate of Re-interventions
time frame: Through study completion, Up to 15 weeks
description: Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
measure: Stent Patency
time frame: Stent placement through stent removal, approximately 60 days
description: Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen
measure: Number of Participants With Successful Technical Stent Placement.
time frame: Intraoperative (stent placement)
description: Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent
measure: Number of Participants With Successful Technical Stent Removal.
time frame: Intraoperative (stent removal)
description: Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events
measure: Acute Cholecystitis Recurrence
time frame: Through study completion, up to 15 weeks
description: Recurrence of acute cholecystitis and its management post AXIOS stent removal
measure: Number of Cumulative Hospital and ICU Days
time frame: Through study completion, up to 15 weeks
description: Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis
arm group label: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
arm group type: Experimental
description: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
intervention type: Device
intervention name: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
description: Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
arm group label: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shayan Irani, MBBS, MD
role: Principal Investigator
affiliation: Virginia Mason Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: United States
country: Canada
responsible party type: Sponsor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: Undecided
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