<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/NCT01699542</url>
  </required_header>
  <id_info>
    <org_study_id>90913904</org_study_id>
    <nct_id>NCT01699542</nct_id>
  </id_info>
  <brief_title>WallFlex Esophageal Fully Covered (FC) Benign Anastomotic Stricture</brief_title>
  <acronym>E7025</acronym>
  <official_title>A Multi-Center, Prospective, Randomized (RCT) Study Comparing WallFlex® Esophageal Fully Covered (FC) Metal Stent to Bougie Dilation for the Treatment of Refractory Anastomotic Esophageal Strictures</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this of this study is to compare the safety and effectiveness of temporary&#xD;
      indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of&#xD;
      refractory anastomotic esophageal strictures&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2013</start_date>
  <completion_date type="Actual">September 25, 2016</completion_date>
  <primary_completion_date type="Actual">September 25, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Dilation Procedures</measure>
    <time_frame>12 months</time_frame>
    <description>Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Technical Stent Placement Success</measure>
    <time_frame>12 months</time_frame>
    <description>Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Technical Stent Removal Success</measure>
    <time_frame>12 months</time_frame>
    <description>Technical stent removal success is defined as the ability to remove the stent without complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Satisfaction With the Therapy</measure>
    <time_frame>Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
    <description>Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Report of Pain</measure>
    <time_frame>Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
    <description>Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life Overall Health Score</measure>
    <time_frame>Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
    <description>Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recurrence of Dysphagia</measure>
    <time_frame>12 months</time_frame>
    <description>Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Stent Migrations</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of stent migrations with or without symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Reinterventions Within 12 Months Following the Initial Study Treatment</measure>
    <time_frame>12 months</time_frame>
    <description>Number of reinterventions within 12 months following the initial study treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Refractory Anastomotic Esophageal Strictures</condition>
  <arm_group>
    <arm_group_label>Metal Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bougie Dilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WallFlex Esophageal RX Fully Covered Stent</intervention_name>
    <description>Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
    <arm_group_label>Metal Stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Esophageal Bougie Dilator Per Investigator preference</intervention_name>
    <description>Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
    <arm_group_label>Bougie Dilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Esophageal anastomotic stricture post esophagectomy (esophagogastric&#xD;
        strictures).&#xD;
&#xD;
          -  Esophagectomy performed at the same institution where patient enrollment and follow-up&#xD;
             is planned.&#xD;
&#xD;
          -  Two dilations to at least 16 mm in diameter since esophagectomy.&#xD;
&#xD;
          -  1st dilation no more than 6 months post esophagectomy and 2nd dilation within 6 months&#xD;
             of 1st dilation to 16mm.&#xD;
&#xD;
          -  Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow&#xD;
             liquids only) or 4 (unable to swallow liquids) at baseline.&#xD;
&#xD;
          -  Unable to pass a standard endoscope (approx. 9.8 mm diameter).&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Willing and able to comply with the study procedures and provide&#xD;
&#xD;
        Exclusion Criteria:Stricture within 2 cm of the upper esophageal sphincter.&#xD;
&#xD;
          -  Dysphagia related to motility disorder.&#xD;
&#xD;
          -  Non-anastomotic esophageal strictures.&#xD;
&#xD;
          -  Esophagocolonic strictures.&#xD;
&#xD;
          -  Planned adjuvant radiation therapy post esophagectomy.&#xD;
&#xD;
          -  Prior esophageal stent placements post esophagectomy.&#xD;
&#xD;
          -  Active erosive esophagitis.&#xD;
&#xD;
          -  Sensitivity to any components of the stent or delivery system.&#xD;
&#xD;
          -  Concurrent medical condition that would affect the investigator's ability to evaluate&#xD;
             the patient's condition or could compromise patient safety. Participation in a&#xD;
             clinical trial evaluating an investigational device within 3 months prior to&#xD;
             enrollment in this study.&#xD;
&#xD;
          -  Stricture length &gt; 5 cm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter D. Siersema, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05612-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <state>CE</state>
        <zip>3015</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitets Sjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>S-14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Netherlands</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>May 10, 2021</results_first_submitted>
  <results_first_submitted_qc>June 4, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2021</results_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Refractory Anastomotic esophageal strictures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Metal Stent</title>
          <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
        </group>
        <group group_id="P2">
          <title>Bougie Dilation</title>
          <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Metal Stent</title>
          <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
        </group>
        <group group_id="B2">
          <title>Bougie Dilation</title>
          <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.6" spread="6.3"/>
                    <measurement group_id="B2" value="66.6" spread="7.7"/>
                    <measurement group_id="B3" value="66.6" spread="6.9"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Esophagectomy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Transthoracic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transhiatal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maximum Dilation</title>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.4" spread="0.9"/>
                    <measurement group_id="B2" value="15.9" spread="2.0"/>
                    <measurement group_id="B3" value="16.2" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dysphagia Score</title>
          <description>Dysphagia Scoring System (scale range from 0 to 4):&#xD;
Dysphagia Score = 0: ability to eat a normal diet Dysphagia Score = 1: ability to eat some solids Dysphagia Score = 2: ability to eat some semisolids only Dysphagia Score = 3: ability to swallow liquids only Dysphagia Score = 4: complete dysphagia&#xD;
A lower score indicates a better outcome. A higher score indicates a worse outcome.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Dysphagia Score = 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dysphagia Score &gt; 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Pretreatment Dilations</title>
          <units>Pretreatment Dilations</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.0" spread="0.0"/>
                    <measurement group_id="B2" value="2.4" spread="1.0"/>
                    <measurement group_id="B3" value="2.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quality of Life Overall Health Score</title>
          <description>Quality of life scale measuring overall health score. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.0" lower_limit="50.0" upper_limit="70.0"/>
                    <measurement group_id="B2" value="80.0" lower_limit="70.0" upper_limit="80.0"/>
                    <measurement group_id="B3" value="70.0" lower_limit="60" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Dilation Procedures</title>
        <description>Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Dilation Procedures</title>
          <description>Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.</description>
          <units>Dilation procedures</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="5.4"/>
                    <measurement group_id="O2" value="2.4" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.159</p_value>
            <method>Generalized Linear Model</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Technical Stent Placement Success</title>
        <description>Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.</description>
        <time_frame>12 months</time_frame>
        <population>Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent placement for the Bougie arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Technical Stent Placement Success</title>
          <description>Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.</description>
          <population>Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent placement for the Bougie arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Technical Stent Removal Success</title>
        <description>Technical stent removal success is defined as the ability to remove the stent without complications.</description>
        <time_frame>12 months</time_frame>
        <population>Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent and therefore underwent stent removal. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent removal for the Bougie arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Technical Stent Removal Success</title>
          <description>Technical stent removal success is defined as the ability to remove the stent without complications.</description>
          <population>Outcome measure only applicable to participants in the Metal Stent arm, as only participants in the Metal Stent arm received a stent and therefore underwent stent removal. Participants in the Bougie Dilation arm did not receive a stent and therefore there is no data to collect regarding technical success of stent removal for the Bougie arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Satisfaction With the Therapy</title>
        <description>Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).</description>
        <time_frame>Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Satisfaction With the Therapy</title>
          <description>Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="7.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="9.5" lower_limit="7.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="6.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="8.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="8.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="8.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="9.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="7.5" upper_limit="10.0"/>
                    <measurement group_id="O2" value="9.0" lower_limit="7.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="7.5" upper_limit="10.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="8.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient's Report of Pain</title>
        <description>Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).</description>
        <time_frame>Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Patient's Report of Pain</title>
          <description>Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality Of Life Overall Health Score</title>
        <description>Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.</description>
        <time_frame>Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Quality Of Life Overall Health Score</title>
          <description>Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="65.0" upper_limit="75.0"/>
                    <measurement group_id="O2" value="75.0" lower_limit="70.0" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="70.0" upper_limit="75.0"/>
                    <measurement group_id="O2" value="80.0" lower_limit="60.0" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0" lower_limit="75.0" upper_limit="85.0"/>
                    <measurement group_id="O2" value="80.0" lower_limit="70.0" upper_limit="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0" lower_limit="75.0" upper_limit="80.0"/>
                    <measurement group_id="O2" value="77.5" lower_limit="56.0" upper_limit="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="60.0" upper_limit="85.0"/>
                    <measurement group_id="O2" value="85.0" lower_limit="70.0" upper_limit="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" lower_limit="62.5" upper_limit="75.0"/>
                    <measurement group_id="O2" value="85.0" lower_limit="60.0" upper_limit="90."/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="62.5" upper_limit="80.0"/>
                    <measurement group_id="O2" value="80.0" lower_limit="70.0" upper_limit="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="67.5" upper_limit="85.0"/>
                    <measurement group_id="O2" value="70.0" lower_limit="70.0" upper_limit="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure</title>
        <description>Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure</title>
          <description>Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Non-serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recurrence of Dysphagia</title>
        <description>Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recurrence of Dysphagia</title>
          <description>Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="24" upper_limit="71"/>
                    <measurement group_id="O2" value="33" lower_limit="21" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Stent Migrations</title>
        <description>Total number of stent migrations with or without symptoms.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Stent Migrations</title>
          <description>Total number of stent migrations with or without symptoms.</description>
          <units>stent migrations</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Reinterventions Within 12 Months Following the Initial Study Treatment</title>
        <description>Number of reinterventions within 12 months following the initial study treatment.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Metal Stent</title>
            <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
          </group>
          <group group_id="O2">
            <title>Bougie Dilation</title>
            <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Reinterventions Within 12 Months Following the Initial Study Treatment</title>
          <description>Number of reinterventions within 12 months following the initial study treatment.</description>
          <units>reinterventions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="5.3"/>
                    <measurement group_id="O2" value="2.9" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data collected for events related to the stent/bougie dilator and/or the procedure, from the time the participant signed the informed consent and was randomized to the study, until completion of the 12 month follow-up visit (occurring 12 months post-initial study treatment).</time_frame>
      <desc>Collected and reported only on those Adverse Events (Serious and Non-serious) related to the stent/bougie dilator and/or the procedure.</desc>
      <group_list>
        <group group_id="E1">
          <title>Metal Stent</title>
          <description>The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
WallFlex Esophageal RX Fully Covered Stent: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell</description>
        </group>
        <group group_id="E2">
          <title>Bougie Dilation</title>
          <description>Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.&#xD;
Esophageal Bougie Dilator Per Investigator preference: Commercially available Esophageal Bougie Dilator Per Investigator preference</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>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="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>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="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Recurrent Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Epigastric Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Retching due to Foreign Body Sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Foreign Body Sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Thoracic Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="9"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joyce Peetermans, PhD - Vice President, Global Clinical Programs</name_or_title>
      <organization>Boston Scientific Corporation</organization>
      <phone>508-683-4211</phone>
      <email>Joyce.Peetermans@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/NCT01699542
org study id: 90913904
nct id: NCT01699542
lead sponsor: 
has dmc: No
The purpose of this of this study is to compare the safety and effectiveness of temporary
      indwell of the WallFlex Esophageal FC Metal Stent to Bougie Dilation for the treatment of
      refractory anastomotic esophageal strictures
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Dilation Procedures
time frame: 12 months
description: Number of dilation procedures for the management of dysphagia within 12 months following initial study treatment.
measure: Number of Participants With Technical Stent Placement Success
time frame: 12 months
description: Technical stent placement success is defined as the ability to deploy the stent in satisfactory position across the stricture.
measure: Number of Participants With Technical Stent Removal Success
time frame: 12 months
description: Technical stent removal success is defined as the ability to remove the stent without complications.
measure: Patient's Satisfaction With the Therapy
time frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
description: Patient's satisfaction with the therapy (scored by a visual analog scale) assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Patient Satisfaction with Therapy scale ranges from 0-10. The minimum on this scale is 0 (0 being completely unsatisfied with the therapy; a worse outcome) and the maximum on this scale is 10 (10 being completely satisfied with the therapy; a better outcome).
measure: Patient's Report of Pain
time frame: Baseline, Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
description: Patient's report of pain (scored by a visual analog scale) assessed at Baseline, day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. Pain Numerical Rating Scale ranges from 0-10. The minimum on this scale is 0 (0 being no pain; a better outcome) and the maximum on this scale is 10 (10 being worst pain ever; a worse outcome).
measure: Quality Of Life Overall Health Score
time frame: Day 2, Week 2, Month 1, Month 2, Month 3, Month 6, Month 9, and Month 12
description: Quality of life scale measuring overall health score assessed at day 2, week 2, month 1, month 2, month 3, month 6, month 9, and month 12. The scale is numbered from 0 to 100. 0 is the worst health the participant can imagine. 100 is the best health the participant can imagine. A lower score indicates a worse outcome. A higher score indicates a better outcome.
measure: Occurrence and Severity of Adverse Events Related to the Stent/Bougie Dilator and/or the Procedure
time frame: 12 months
description: Occurrence and severity of adverse events related to the stent/bougie dilator and/or the procedure.
measure: Time to Recurrence of Dysphagia
time frame: 12 months
description: Time to recurrence of dysphagia, defined as inability of a normal diameter gastroscope (9.8mm) to pass the stricture.
measure: Total Number of Stent Migrations
time frame: 12 months
description: Total number of stent migrations with or without symptoms.
measure: Number of Reinterventions Within 12 Months Following the Initial Study Treatment
time frame: 12 months
description: Number of reinterventions within 12 months following the initial study treatment.
arm group label: Metal Stent
arm group type: Active Comparator
description: The WallFlex Biliary Fully Covered Esophageal Stent System is being evaluated for treatment of refractory anastomotic esophageal strictures.
arm group label: Bougie Dilation
arm group type: Active Comparator
description: Esophageal Bougie Dilator commercially available devices used per Investigator preference are being evaluated for treatment of refractory anastomotic esophageal strictures.
intervention type: Device
intervention name: WallFlex Esophageal RX Fully Covered Stent
description: Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
arm group label: Metal Stent
intervention type: Device
intervention name: Esophageal Bougie Dilator Per Investigator preference
description: Commercially available Esophageal Bougie Dilator Per Investigator preference
arm group label: Bougie Dilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter D. Siersema, MD
role: Principal Investigator
affiliation: Study Principal Investigator
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Netherlands
country: Sweden
responsible party type: Sponsor
mesh term: Esophageal Stenosis
mesh term: Constriction, Pathologic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 