<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/NCT01685229</url>
  </required_header>
  <id_info>
    <org_study_id>CPR005028</org_study_id>
    <nct_id>NCT01685229</nct_id>
  </id_info>
  <brief_title>Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis</brief_title>
  <acronym>MERLOT</acronym>
  <official_title>Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acclarent</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acclarent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS)&#xD;
      patients treated with balloon sinus dilation (BSD) versus continued medical management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Actual">August 1, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline</measure>
    <time_frame>24 weeks post treatment</time_frame>
    <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.&#xD;
The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;) and a total score is normalized from 0 (worst) to 100 (best).&#xD;
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.&#xD;
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).&#xD;
Higher score indicates greater improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline</measure>
    <time_frame>12, 24, and 52 weeks post treatment</time_frame>
    <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in RSDI</measure>
    <time_frame>12, 24 and 52 weeks post treatment</time_frame>
    <description>The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 (&quot;Never&quot;) to 4 (&quot;Always&quot;) and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.&#xD;
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SNOT-20</measure>
    <time_frame>12 weeks, 24 weeks, 52 weeks post treatment</time_frame>
    <description>The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.&#xD;
Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).&#xD;
Lower score indicates greater improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease-specific Medication Usage</measure>
    <time_frame>12, 24 and 52 weeks post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missed Days Work/School</measure>
    <time_frame>12, 24 and 52 weeks post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sinus-related Medical Care Visits</measure>
    <time_frame>12 weeks, 24 weeks, 52 weeks post treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sinus Infections</measure>
    <time_frame>24 and 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Requiring Revision for Subjects Electing BSD</measure>
    <time_frame>52 weeks</time_frame>
    <description>A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Return to Normal Activity (RTNA)</measure>
    <time_frame>2 weeks post treatment</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">198</enrollment>
  <condition>Sinusitis</condition>
  <arm_group>
    <arm_group_label>Balloon Sinus Dilation</arm_group_label>
    <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Management</arm_group_label>
    <description>Subjects with chronic sinusitis electing to continue with medical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balloon sinus dilation</intervention_name>
    <description>Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.</description>
    <arm_group_label>Balloon Sinus Dilation</arm_group_label>
    <other_name>Acclarent Balloon Sinuplasty System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical Management</intervention_name>
    <description>Subjects who select to continue on medical management rather than have a BSD procedure.</description>
    <arm_group_label>Medical Management</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult subjects age 19 or older with radiographically documented CRS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females aged 19 or greater&#xD;
&#xD;
          -  Diagnosis of Chronic Rhinosinusitis (CRS)&#xD;
&#xD;
          -  Failure of appropriate medical management&#xD;
&#xD;
          -  Radiographic evidence of inflammation of the paranasal sinuses&#xD;
&#xD;
          -  Surgical candidate&#xD;
&#xD;
          -  Willing and able to read and sign the Informed Consent Form and remain compliant with&#xD;
             the protocol and study procedures&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not suitable for balloon dilation for all peripheral sinuses that require treatment&#xD;
&#xD;
          -  Clinically significant illness that may interfere with the evaluation of the study&#xD;
&#xD;
          -  Patients involved in other clinical studies 30 days prior to study&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Patients unable to adhere to follow-up schedule or protocol requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Spencer Payne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Melroy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgia Nasal and Sinus Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Boris Karanfilov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio Sinus Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vidalia</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frisco</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beaver Dam</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>April 29, 2016</results_first_submitted>
  <results_first_submitted_qc>February 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 13, 2019</results_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication is planned</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Balloon Sinus Dilation</title>
          <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
        </group>
        <group group_id="P2">
          <title>Medical Management</title>
          <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="146"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subjects missing Study Exit form</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Balloon Sinus Dilation</title>
          <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
        </group>
        <group group_id="B2">
          <title>Medical Management</title>
          <description>Subjects with chronic sinusitis electing to continue medical therapy</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="146"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="198"/>
          </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="50.5" spread="14.8"/>
                    <measurement group_id="B2" value="46.4" spread="13.3"/>
                    <measurement group_id="B3" value="49.4" spread="14.5"/>
                  </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="75"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline</title>
        <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.&#xD;
The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;) and a total score is normalized from 0 (worst) to 100 (best).&#xD;
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.&#xD;
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).&#xD;
Higher score indicates greater improvement.</description>
        <time_frame>24 weeks post treatment</time_frame>
        <population>Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM</population>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline</title>
          <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.&#xD;
The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;) and a total score is normalized from 0 (worst) to 100 (best).&#xD;
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.&#xD;
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).&#xD;
Higher score indicates greater improvement.</description>
          <population>Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="23.7"/>
                    <measurement group_id="O2" value="27.0" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline</title>
        <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.</description>
        <time_frame>12, 24, and 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline</title>
          <description>The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (&quot;during the past 8 weeks&quot;) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 (&quot;7-8 Weeks&quot;) to 4 (&quot;0 Weeks&quot;), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CSS Total Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" spread="17.9"/>
                    <measurement group_id="O2" value="34.3" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Total Wk 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3" spread="20.2"/>
                    <measurement group_id="O2" value="60.2" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Total Wk 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" spread="21.7"/>
                    <measurement group_id="O2" value="29.9" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Total Wk 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" spread="20.9"/>
                    <measurement group_id="O2" value="56.2" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Total Wk 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" spread="22.7"/>
                    <measurement group_id="O2" value="21.9" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" spread="22.3"/>
                    <measurement group_id="O2" value="26.4" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Wk 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" spread="25.7"/>
                    <measurement group_id="O2" value="56.0" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Wk 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.8" spread="28.1"/>
                    <measurement group_id="O2" value="31.0" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Wk 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.1" spread="24.5"/>
                    <measurement group_id="O2" value="60.9" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom WK 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.7" spread="29.9"/>
                    <measurement group_id="O2" value="35.2" spread="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Wk 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" spread="24.0"/>
                    <measurement group_id="O2" value="57.7" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Symptom Wk 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6" spread="29.4"/>
                    <measurement group_id="O2" value="36.4" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" spread="21.4"/>
                    <measurement group_id="O2" value="42.1" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4" spread="26.0"/>
                    <measurement group_id="O2" value="56.4" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5" spread="27.4"/>
                    <measurement group_id="O2" value="12.9" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="25.8"/>
                    <measurement group_id="O2" value="61.7" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" spread="28.8"/>
                    <measurement group_id="O2" value="18.8" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" spread="24.8"/>
                    <measurement group_id="O2" value="62.7" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSS Medication Wk 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6" spread="24.6"/>
                    <measurement group_id="O2" value="23.5" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in RSDI</title>
        <description>The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 (&quot;Never&quot;) to 4 (&quot;Always&quot;) and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.&#xD;
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).</description>
        <time_frame>12, 24 and 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Change in RSDI</title>
          <description>The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 (&quot;Never&quot;) to 4 (&quot;Always&quot;) and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.&#xD;
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RSDI Total Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.9" spread="25.3"/>
                    <measurement group_id="O2" value="39.5" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" spread="17.8"/>
                    <measurement group_id="O2" value="26.0" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.7" spread="24.2"/>
                    <measurement group_id="O2" value="-14.7" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="19.0"/>
                    <measurement group_id="O2" value="22.6" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.0" spread="26.4"/>
                    <measurement group_id="O2" value="-18.1" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="19.1"/>
                    <measurement group_id="O2" value="18.7" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Total Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.5" spread="24.9"/>
                    <measurement group_id="O2" value="-19.9" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="9.7"/>
                    <measurement group_id="O2" value="16.8" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="7.0"/>
                    <measurement group_id="O2" value="11.4" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.9" spread="9.4"/>
                    <measurement group_id="O2" value="-6.0" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="7.7"/>
                    <measurement group_id="O2" value="10.1" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.1" spread="10.4"/>
                    <measurement group_id="O2" value="-7.3" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="7.2"/>
                    <measurement group_id="O2" value="9.2" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Physical Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.3" spread="9.9"/>
                    <measurement group_id="O2" value="-7.9" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" spread="8.3"/>
                    <measurement group_id="O2" value="11.5" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="6.1"/>
                    <measurement group_id="O2" value="7.3" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" spread="8.2"/>
                    <measurement group_id="O2" value="-4.8" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="6.0"/>
                    <measurement group_id="O2" value="6.5" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.4" spread="8.5"/>
                    <measurement group_id="O2" value="-5.4" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="6.2"/>
                    <measurement group_id="O2" value="5.4" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Functional Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="8.1"/>
                    <measurement group_id="O2" value="-5.7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="9.7"/>
                    <measurement group_id="O2" value="11.3" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="5.7"/>
                    <measurement group_id="O2" value="7.5" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="9.4"/>
                    <measurement group_id="O2" value="-3.4" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="6.0"/>
                    <measurement group_id="O2" value="5.9" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.5" spread="9.8"/>
                    <measurement group_id="O2" value="-5.4" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="6.4"/>
                    <measurement group_id="O2" value="4.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RSDI Emotional Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" spread="9.5"/>
                    <measurement group_id="O2" value="-6.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SNOT-20</title>
        <description>The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.&#xD;
Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).&#xD;
Lower score indicates greater improvement.</description>
        <time_frame>12 weeks, 24 weeks, 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SNOT-20</title>
          <description>The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.&#xD;
Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).&#xD;
Lower score indicates greater improvement.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SNOT-20 Total Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.0"/>
                    <measurement group_id="O2" value="2.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.8"/>
                    <measurement group_id="O2" value="1.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.1"/>
                    <measurement group_id="O2" value="-0.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.8"/>
                    <measurement group_id="O2" value="1.5" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="1.1"/>
                    <measurement group_id="O2" value="-1.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.8"/>
                    <measurement group_id="O2" value="1.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="1.2"/>
                    <measurement group_id="O2" value="-1.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.2"/>
                    <measurement group_id="O2" value="2.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.9"/>
                    <measurement group_id="O2" value="1.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 12 Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="1.2"/>
                    <measurement group_id="O2" value="-0.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.0"/>
                    <measurement group_id="O2" value="1.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 24 Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.2"/>
                    <measurement group_id="O2" value="-1.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.9"/>
                    <measurement group_id="O2" value="1.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Social-Emotional Week 52 Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.4"/>
                    <measurement group_id="O2" value="-1.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.8"/>
                    <measurement group_id="O2" value="1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.0"/>
                    <measurement group_id="O2" value="-0.9" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.8"/>
                    <measurement group_id="O2" value="1.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="1.1"/>
                    <measurement group_id="O2" value="-1.0" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.8"/>
                    <measurement group_id="O2" value="1.2" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Total Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="1.2"/>
                    <measurement group_id="O2" value="-1.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNOT-20 Symptom Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.0"/>
                    <measurement group_id="O2" value="2.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Disease-specific Medication Usage</title>
        <time_frame>12, 24 and 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Disease-specific Medication Usage</title>
          <units>Medications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Oral Antibiotics Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" spread="15.4"/>
                    <measurement group_id="O2" value="22.8" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="8.4"/>
                    <measurement group_id="O2" value="6.6" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.2" spread="17.0"/>
                    <measurement group_id="O2" value="-16.7" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="6.6"/>
                    <measurement group_id="O2" value="2.8" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.9" spread="15.8"/>
                    <measurement group_id="O2" value="-20.5" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="5.9"/>
                    <measurement group_id="O2" value="1.8" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Antibiotics Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.8" spread="15.5"/>
                    <measurement group_id="O2" value="-22.4" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="10.4"/>
                    <measurement group_id="O2" value="8.4" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="9.8"/>
                    <measurement group_id="O2" value="2.6" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="13.7"/>
                    <measurement group_id="O2" value="-6.5" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="3.6"/>
                    <measurement group_id="O2" value="0.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.5" spread="9.9"/>
                    <measurement group_id="O2" value="-7.9" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="13.9"/>
                    <measurement group_id="O2" value="2.6" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oral Steroids Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="17.0"/>
                    <measurement group_id="O2" value="-6.4" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.0" spread="29.6"/>
                    <measurement group_id="O2" value="47.2" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7" spread="40.3"/>
                    <measurement group_id="O2" value="69.1" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 12 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.3" spread="44.2"/>
                    <measurement group_id="O2" value="21.1" spread="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" spread="42.6"/>
                    <measurement group_id="O2" value="66.0" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.1" spread="46.6"/>
                    <measurement group_id="O2" value="18.4" spread="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" spread="41.1"/>
                    <measurement group_id="O2" value="57.0" spread="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal Steroid Spray Week 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.5" spread="46.0"/>
                    <measurement group_id="O2" value="10.0" spread="52.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Missed Days Work/School</title>
        <time_frame>12, 24 and 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Missed Days Work/School</title>
          <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="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="9.2"/>
                    <measurement group_id="O2" value="1.4" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.8"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="2.9"/>
                    <measurement group_id="O2" value="0.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 24 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="4.4"/>
                    <measurement group_id="O2" value="-1.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wk 52 Change from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="3.9"/>
                    <measurement group_id="O2" value="-1.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sinus-related Medical Care Visits</title>
        <time_frame>12 weeks, 24 weeks, 52 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sinus-related Medical Care Visits</title>
          <units>Visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sinus-Related Visits at Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="2.1"/>
                    <measurement group_id="O2" value="1.2" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus-Related Visits through 12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0.1" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus-Related Visits through 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                    <measurement group_id="O2" value="0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus-Related Visits through 52 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.5"/>
                    <measurement group_id="O2" value="0.1" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sinus Infections</title>
        <time_frame>24 and 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sinus Infections</title>
          <units>Sinus infections</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sinus Infections through 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.6"/>
                    <measurement group_id="O2" value="0.3" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus Infections through 52 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.8"/>
                    <measurement group_id="O2" value="0.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Requiring Revision for Subjects Electing BSD</title>
        <description>A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.</description>
        <time_frame>52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Requiring Revision for Subjects Electing BSD</title>
          <description>A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure</title>
        <time_frame>52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medical Management</title>
            <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure</title>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Return to Normal Activity (RTNA)</title>
        <time_frame>2 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Sinus Dilation</title>
            <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
          </group>
          <group group_id="O2">
            <title>In-Office</title>
            <description>BSD subjects treated in an office setting</description>
          </group>
          <group group_id="O3">
            <title>Operating Room</title>
            <description>BSD subjects treating in an Operating Room venue</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Return to Normal Activity (RTNA)</title>
          <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="146"/>
                <count group_id="O2" value="105"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="4.1"/>
                    <measurement group_id="O2" value="2.8" spread="3.7"/>
                    <measurement group_id="O3" value="5.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>No AEs were related to the device</desc>
      <group_list>
        <group group_id="E1">
          <title>Balloon Sinus Dilation</title>
          <description>Subjects with chronic sinusitis electing to have a balloon sinus dilation</description>
        </group>
        <group group_id="E2">
          <title>Medical Management</title>
          <description>Subjects with chronic sinusitis electing to continue medical therapy</description>
        </group>
      </group_list>
      <serious_events>
        <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="1" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI Bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropenic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer, Glioblastoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Bells Palsy, TIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="146"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="49" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="146"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="38" subjects_affected="30" subjects_at_risk="146"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>URI</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="146"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </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>Clinical Manager</name_or_title>
      <organization>Acclarent Inc.</organization>
      <phone>949-453-6408</phone>
      <email>PChen126@ITS.JNJ.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/NCT01685229
org study id: CPR005028
nct id: NCT01685229
lead sponsor: 
has dmc: No
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS)
      patients treated with balloon sinus dilation (BSD) versus continued medical management.
observational model: Cohort
time perspective: Prospective
measure: Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline
time frame: 24 weeks post treatment
description: The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.
The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best).
The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.
Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).
Higher score indicates greater improvement.
measure: Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline
time frame: 12, 24, and 52 weeks post treatment
description: The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.
measure: Change in RSDI
time frame: 12, 24 and 52 weeks post treatment
description: The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.
The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).
measure: Change in SNOT-20
time frame: 12 weeks, 24 weeks, 52 weeks post treatment
description: The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.
Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).
Lower score indicates greater improvement.
measure: Change in Disease-specific Medication Usage
time frame: 12, 24 and 52 weeks post treatment
measure: Missed Days Work/School
time frame: 12, 24 and 52 weeks post treatment
measure: Number of Sinus-related Medical Care Visits
time frame: 12 weeks, 24 weeks, 52 weeks post treatment
measure: Number of Sinus Infections
time frame: 24 and 52 weeks
measure: Number of Subjects Requiring Revision for Subjects Electing BSD
time frame: 52 weeks
description: A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.
measure: Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure
time frame: 52 weeks
measure: Post-operative Return to Normal Activity (RTNA)
time frame: 2 weeks post treatment
arm group label: Balloon Sinus Dilation
description: Subjects with chronic sinusitis electing to have a balloon sinus dilation
arm group label: Medical Management
description: Subjects with chronic sinusitis electing to continue with medical therapy
intervention type: Device
intervention name: Balloon sinus dilation
description: Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.
arm group label: Balloon Sinus Dilation
other name: Acclarent Balloon Sinuplasty System
intervention type: Drug
intervention name: Medical Management
description: Subjects who select to continue on medical management rather than have a BSD procedure.
arm group label: Medical Management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Spencer Payne, MD
role: Principal Investigator
affiliation: University of Virginia
last name: Christopher Melroy, MD
role: Principal Investigator
affiliation: Georgia Nasal and Sinus Institute
last name: Boris Karanfilov, MD
role: Principal Investigator
affiliation: Ohio Sinus Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sinusitis
sharing ipd: Yes
ipd description: Publication is planned
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 