<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/NCT02228720</url>
  </required_header>
  <id_info>
    <org_study_id>P500-0414</org_study_id>
    <nct_id>NCT02228720</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia</brief_title>
  <acronym>EXCEED</acronym>
  <official_title>The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intersect ENT</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intersect ENT</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a feasibility study is to assess the performance, safety and initial signals of&#xD;
      efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis&#xD;
      patients undergoing sinus surgery of peripheral sinus ostia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center, single-arm, open label feasibility study aiming to&#xD;
      enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The&#xD;
      objective of this feasibility study is to assess the performance, safety and initial signals&#xD;
      of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS)&#xD;
      patients undergoing sinus surgery of peripheral sinus ostia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Propel Nova Sinus Implant</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Placement Success Rate</measure>
    <time_frame>Baseline Procedure</time_frame>
    <description>Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ostial Patency</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adhesion/Scarring Grade 2 &amp; 3</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Inflammation</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sino-Nasal Outcome Test (SNOT) 22</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Chronic Sinusitis</condition>
  <arm_group>
    <arm_group_label>Propel Nova Sinus Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Propel Nova Sinus Implant</intervention_name>
    <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days</description>
    <arm_group_label>Propel Nova Sinus Implant</arm_group_label>
    <other_name>Propel Contour Sinus Implant (mometasone furoate, 370 mcg)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is ≥ 18 years of age.&#xD;
&#xD;
          -  Patient is willing and able to comply with protocol requirements.&#xD;
&#xD;
          -  Patient has CS as confirmed by CT scan and defined as symptoms lasting longer than 8&#xD;
             consecutive weeks in duration with inflammation of the mucosa of the nose and&#xD;
             paranasal sinuses.&#xD;
&#xD;
          -  Patient's condition and the planned intervention will involve at least two and a&#xD;
             maximum of four peripheral sinuses (frontal or maxillary sinuses or combination of&#xD;
             both).&#xD;
&#xD;
          -  Patient is a candidate for a planned intervention involving sinus surgery in the&#xD;
             operating room or office setting.&#xD;
&#xD;
          -  Patient has nasal polyps no greater than grade 2.&#xD;
&#xD;
          -  Patient with nasal polyps greater than 2 are eligible after their reduction/removal&#xD;
             during ESS without significant complications that would confound the study results and&#xD;
             leaving the patient's anatomy amenable to sinus implant placement, as judged by the&#xD;
             operating physician.&#xD;
&#xD;
          -  Female patients of child-bearing potential must not be pregnant and must agree to not&#xD;
             become pregnant during the course of the study.&#xD;
&#xD;
          -  Female patients of child-bearing potential must agree to use consistent and acceptable&#xD;
             method/s of birth control during the course of the study.&#xD;
&#xD;
          -  CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.&#xD;
&#xD;
          -  Patient has a minimum total CT stage (Lund-Mackay method) of 6.&#xD;
&#xD;
          -  Patient has disease in frontal and/or maxillary sinuses confirmed by CT scan.&#xD;
&#xD;
          -  Planned ESS includes bilateral ethmoidectomy (if judged necessary), frontal sinus&#xD;
             surgery using Draf II (A or B) dissection and/or balloon dilation, with minimum of&#xD;
             5-mm diameter opening created. In the case of maxillary sinus surgery, traditional&#xD;
             antrostomy or balloon dilation, with or without removal of uncinate process, should be&#xD;
             performed with minimum of 5-mm diameter opening created.&#xD;
&#xD;
          -  Technique used for frontal or maxillary sinus surgery was the same on both sides (e.g.&#xD;
             surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both&#xD;
             bilaterally)&#xD;
&#xD;
          -  Septoplasty for access to the ostio-meatal complex is permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has presence of grade 3 or 4 polyposis, unless removed during surgery and&#xD;
             preceding implant placement.&#xD;
&#xD;
          -  Patient has presence of adhesions/scarring grades 3 or 4, unless removed during&#xD;
             surgery and preceding implant placement.&#xD;
&#xD;
          -  Patient has known history of immune deficiency (e.g., IGG subclass deficiency or IGA&#xD;
             deficiency, HIV).&#xD;
&#xD;
          -  Patient has concurrent condition requiring active chemotherapy and/or immunotherapy&#xD;
             management for the disease (e.g., cancer, HIV, etc.).&#xD;
&#xD;
          -  Patient has oral-steroid dependent condition such as COPD, asthma or other condition.&#xD;
&#xD;
          -  Patient has known history of allergy or intolerance to corticosteroids or mometasone&#xD;
             furoate.&#xD;
&#xD;
          -  Patient has clinical evidence of acute bacterial sinusitis (e.g. acute increase in&#xD;
             purulent discharge, fever, facial pain etc.).&#xD;
&#xD;
          -  Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g. bone&#xD;
             erosion on prior CT scan, necrotic sinus tissue, etc.).&#xD;
&#xD;
          -  Patient has evidence of disease or condition expected to compromise survival or&#xD;
             ability to complete follow-up assessments during the 90-day period.&#xD;
&#xD;
          -  Patient is currently participating in another clinical trial.&#xD;
&#xD;
          -  Patient has history of insulin dependent diabetes mellitus.&#xD;
&#xD;
          -  Patient has previously undergone ESS and experienced a CSF leak or has residual&#xD;
             compromised vision as a result of a complication in a prior ESS procedure.&#xD;
&#xD;
          -  Patient has known dehiscence of the lamina papyracea.&#xD;
&#xD;
          -  Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes&#xD;
             simplex, chickenpox or measles).&#xD;
&#xD;
          -  Significant complication during the current peripheral ostia surgery/such as excessive&#xD;
             blood loss, CSF leak or punctured lamina papyracea.&#xD;
&#xD;
          -  Current surgical intervention (operating room or office setting) is aborted for any&#xD;
             reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William J. Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>South Florida ENT Associates, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Florida ENT Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Sinus Institute</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>August 23, 2016</results_first_submitted>
  <results_first_submitted_qc>April 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 4, 2017</results_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Sinusitis</keyword>
  <keyword>Endoscopic Sinus Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Propel Nova Sinus Implant</title>
          <description>Sinus stent with steroid coating (370 ug mometasone furoate)&#xD;
Propel Nova Sinus Implant: Sinus stent with steroid coating (370 ug mometasone furoate)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Open Label - Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Open Label - Day 30</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open Label - Day 90</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients and sinuses in whom placement of a Propel Nova Sinus Implant was attempted.</population>
      <group_list>
        <group group_id="B1">
          <title>Propel Nova Sinus Implant</title>
          <description>Steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </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="50.6" spread="13.24"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lund-Mackay Score (CT scan)</title>
          <description>The severity of sinus mucosal inflammation or fluid accumulation scored as 0 (complete lucency), 1 (partial lucency) or 2 (complete opacity).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Frontal Sinuses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.5" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maxillary Sinuses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" spread="0.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Device Placement Success Rate</title>
        <description>Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.</description>
        <time_frame>Baseline Procedure</time_frame>
        <population>Attempted frontal and maxillary sinus ostia</population>
        <group_list>
          <group group_id="O1">
            <title>Propel Nova Sinus Implant</title>
            <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</description>
          </group>
        </group_list>
        <measure>
          <title>Device Placement Success Rate</title>
          <description>Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.</description>
          <population>Attempted frontal and maxillary sinus ostia</population>
          <units>Percentage of attempted sinuses</units>
          <param>Number</param>
          <units_analyzed>Sinuses</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sinuses</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ostial Patency</title>
        <description>Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)</description>
        <time_frame>Baseline, Day 30, Day 90</time_frame>
        <population>Frontal and maxillary sinus ostia</population>
        <group_list>
          <group group_id="O1">
            <title>Propel Nova Sinus Implant</title>
            <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</description>
          </group>
        </group_list>
        <measure>
          <title>Ostial Patency</title>
          <description>Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)</description>
          <population>Frontal and maxillary sinus ostia</population>
          <units>percentage of evaluable sinuses</units>
          <param>Number</param>
          <units_analyzed>Sinuses</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sinuses</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adhesion/Scarring Grade 2 &amp; 3</title>
        <description>Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)</description>
        <time_frame>Baseline, Day 30, Day 90</time_frame>
        <population>Frontal and maxillary sinus ostia</population>
        <group_list>
          <group group_id="O1">
            <title>Propel Nova Sinus Implant</title>
            <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</description>
          </group>
        </group_list>
        <measure>
          <title>Adhesion/Scarring Grade 2 &amp; 3</title>
          <description>Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)</description>
          <population>Frontal and maxillary sinus ostia</population>
          <units>percentage of evaluable sinuses</units>
          <param>Number</param>
          <units_analyzed>Sinuses</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sinuses</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Degree of Inflammation</title>
        <description>Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)</description>
        <time_frame>Baseline, Day 30, Day 90</time_frame>
        <population>Frontal and maxillary sinus ostia</population>
        <group_list>
          <group group_id="O1">
            <title>Propel Nova Sinus Implant</title>
            <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</description>
          </group>
        </group_list>
        <measure>
          <title>Degree of Inflammation</title>
          <description>Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)</description>
          <population>Frontal and maxillary sinus ostia</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Sinuses</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sinuses</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8" spread="23.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" spread="23.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Frontal Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" spread="25.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6" spread="24.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="13.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90 - Maxillary Sinuses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Sinuses</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sino-Nasal Outcome Test (SNOT) 22</title>
        <description>Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110</description>
        <time_frame>Baseline, Day 30, Day 90</time_frame>
        <population>Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate</population>
        <group_list>
          <group group_id="O1">
            <title>Propel Nova Sinus Implant</title>
            <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</description>
          </group>
        </group_list>
        <measure>
          <title>Sino-Nasal Outcome Test (SNOT) 22</title>
          <description>Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110</description>
          <population>Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate</population>
          <units>units 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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 90</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Propel Nova Sinus Implant</title>
          <description>Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate gradually released over time</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, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </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="9" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vasovagal Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </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="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Chronic Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sinus Drainage, green</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Crusting in nares</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>James Stambaugh</name_or_title>
      <organization>Intersect ENT</organization>
      <phone>6506412103</phone>
      <email>jstambaugh@intersectent.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/NCT02228720
org study id: P500-0414
nct id: NCT02228720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a feasibility study is to assess the performance, safety and initial signals of
      efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis
      patients undergoing sinus surgery of peripheral sinus ostia.
This is a prospective, single-center, single-arm, open label feasibility study aiming to
      enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The
      objective of this feasibility study is to assess the performance, safety and initial signals
      of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS)
      patients undergoing sinus surgery of peripheral sinus ostia.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Propel Nova Sinus Implant
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Device Placement Success Rate
time frame: Baseline Procedure
description: Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
measure: Ostial Patency
time frame: Baseline, Day 30, Day 90
description: Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
measure: Adhesion/Scarring Grade 2 & 3
time frame: Baseline, Day 30, Day 90
description: Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
measure: Degree of Inflammation
time frame: Baseline, Day 30, Day 90
description: Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
measure: Sino-Nasal Outcome Test (SNOT) 22
time frame: Baseline, Day 30, Day 90
description: Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110
arm group label: Propel Nova Sinus Implant
arm group type: Experimental
description: Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
intervention type: Device
intervention name: Propel Nova Sinus Implant
description: Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
arm group label: Propel Nova Sinus Implant
other name: Propel Contour Sinus Implant (mometasone furoate, 370 mcg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William J. Brown, MD
role: Principal Investigator
affiliation: South Florida ENT Associates, PA
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Mometasone Furoate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 