<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/NCT01732536</url>
  </required_header>
  <id_info>
    <org_study_id>P500-1012</org_study_id>
    <nct_id>NCT01732536</nct_id>
  </id_info>
  <brief_title>Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps</brief_title>
  <acronym>RESOLVE</acronym>
  <official_title>A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction</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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic&#xD;
      sinusitis patients with recurrent nasal polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter&#xD;
      study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented&#xD;
      with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy&#xD;
      of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable&#xD;
      self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use&#xD;
      delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The&#xD;
      coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days,&#xD;
      with the majority of drug released within 60 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Nasal Obstruction/Congestion Score</measure>
    <time_frame>90 days</time_frame>
    <description>Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bilateral Polyp Grade</measure>
    <time_frame>90 days</time_frame>
    <description>Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ethmoid Sinus Obstruction</measure>
    <time_frame>90 days</time_frame>
    <description>Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilateral Polyp Grade</measure>
    <time_frame>90 days, 6 months</time_frame>
    <description>Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal Obstruction Symptom Evaluation (NOSE) Score</measure>
    <time_frame>6 months</time_frame>
    <description>NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)</measure>
    <time_frame>90 days, 6 months</time_frame>
    <description>To be indicated for RESS, the following criteria had to be met:&#xD;
Continued to use topical intranasal steroids daily;&#xD;
Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use&#xD;
Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and&#xD;
Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade &gt;=2 on at least one side)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Sinusitis</condition>
  <condition>Nasal Polyps</condition>
  <arm_group>
    <arm_group_label>S8 Sinus Implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S8 Sinus Implant</intervention_name>
    <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses</description>
    <arm_group_label>S8 Sinus Implant</arm_group_label>
    <other_name>SINUVA (mometasone furoate) sinus implant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham procedure</intervention_name>
    <description>In-office bilateral sham procedure</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mometasone furoate nasal spray</intervention_name>
    <description>Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>S8 Sinus Implant</arm_group_label>
    <other_name>Nasonex Nasal Spray</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Candidates for this study had to meet ALL of the following inclusion criteria:&#xD;
&#xD;
        1. General Inclusion Criteria&#xD;
&#xD;
          1. Patient has provided written informed consent using a form approved by the reviewing&#xD;
             IRB.&#xD;
&#xD;
          2. Patient is ≥ 18 years of age.&#xD;
&#xD;
          3. Patient is willing and able to comply with protocol requirements.&#xD;
&#xD;
          4. Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa&#xD;
             of the paranasal sinuses.&#xD;
&#xD;
          5. Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond&#xD;
             the date of last sinus surgery).&#xD;
&#xD;
          6. Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3&#xD;
             only).&#xD;
&#xD;
          7. Patient must have a Grade 2 polyposis on at least 1 ethmoid side.&#xD;
&#xD;
          8. Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once&#xD;
             daily.&#xD;
&#xD;
          9. Patient is indicated for a repeat ESS per the study definition. Patient must have: (i)&#xD;
             a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at&#xD;
             least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick&#xD;
             nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent&#xD;
             symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations&#xD;
             or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had&#xD;
             treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into&#xD;
             polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such&#xD;
             therapy due to intolerance/side effects; (iv) a known history of repeated courses of&#xD;
             treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic&#xD;
             evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.&#xD;
&#xD;
         10. Patient is able to tolerate use of topical/local anesthesia and the implant procedure&#xD;
             in an office or clinic setting.&#xD;
&#xD;
         11. In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is&#xD;
             technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.&#xD;
&#xD;
         12. 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;
         13. 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;
        Exclusion Criteria&#xD;
&#xD;
        Candidates were excluded if they met ANY of the following criteria:&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
          1. Patient had bilateral total ethmoidectomy less than 90 days previously.&#xD;
&#xD;
          2. Patient had Propel implanted postoperatively less than 90 days previously.&#xD;
&#xD;
          3. Patient has presence of adhesions/synechiae Grades 3 or 4.&#xD;
&#xD;
          4. Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.&#xD;
&#xD;
          5. Patient has presence of Grade 4 polyposis.&#xD;
&#xD;
          6. Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA&#xD;
             deficiency, HIV).&#xD;
&#xD;
          7. Patient has concurrent condition requiring active chemotherapy and/or immunotherapy&#xD;
             management for the disease (e.g., cancer, HIV, etc.).&#xD;
&#xD;
          8. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary&#xD;
             disease (COPD), asthma or other condition.&#xD;
&#xD;
          9. Patient has known history of allergy or intolerance to corticosteroids or mometasone&#xD;
             furoate (MF).&#xD;
&#xD;
         10. Patient has known history of resistance or poor response to oral steroids.&#xD;
&#xD;
         11. Patient has presence of physical obstruction that would preclude access to either&#xD;
             ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very&#xD;
             small middle meatus, total obstruction of the nasal passage with severe scarring,&#xD;
             polyposis).&#xD;
&#xD;
         12. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in&#xD;
             purulent discharge, fever, facial pain etc.).&#xD;
&#xD;
         13. 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;
         14. Patient has evidence of disease or condition expected to compromise survival or&#xD;
             ability to complete follow-up assessments during the 6 month follow-up period.&#xD;
&#xD;
         15. Patient is currently participating in or recently participated in another clinical&#xD;
             trial (within the last 30 days).&#xD;
&#xD;
         16. Patient has history of insulin dependent diabetes mellitus.&#xD;
&#xD;
         17. 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;
         18. Patient has completely resected middle turbinate.&#xD;
&#xD;
         19. Patient has known dehiscence of the lamina papyracea.&#xD;
&#xD;
         20. Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes&#xD;
             simplex, chickenpox, or measles).&#xD;
&#xD;
             Ocular Exclusion Criteria&#xD;
&#xD;
         21. Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a&#xD;
             known prior ocular exam indicating IOP &gt;21 mm Hg)&#xD;
&#xD;
         22. Patient has closed angle (with or without the presence of peripheral anterior&#xD;
             synechiae on gonioscopy)&#xD;
&#xD;
         23. Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii)&#xD;
             nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or&#xD;
             higher.&#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>Keith D Forwith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced ENT and Allergy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joseph K Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Virginia Medical School Department of Otolaryngology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Sinus Centers</name>
      <address>
        <city>Atherton</city>
        <state>California</state>
        <zip>94027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center, Sinus Center of Excellence</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Ear, Nose and Throat</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Ear, Nose, Throat &amp; Allergy</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>ENT of Georgia</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University, Department of Otolaryngology-Head &amp; Neck Surgery</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced ENT &amp; Allergy</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Medical Group</name>
      <address>
        <city>Berkeley Heights</city>
        <state>New Jersey</state>
        <zip>07922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany ENT &amp; Allergy Services</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Ear, Nose &amp; Throat Associates</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethlehem ENT Specialty Physicians Associates</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania, Dept of Otolaryngology-Head &amp; Neck Surgery</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Ear, Nose &amp; Throat Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Medical School Department of Otolaryngology</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.</citation>
    <PMID>25266981</PMID>
  </reference>
  <results_reference>
    <citation>Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.</citation>
    <PMID>26992115</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>April 16, 2018</results_first_submitted>
  <results_first_submitted_qc>July 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 20, 2018</results_first_posted>
  <disposition_first_submitted>March 5, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>March 5, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 26, 2015</disposition_first_posted>
  <last_update_submitted>July 18, 2018</last_update_submitted>
  <last_update_submitted_qc>July 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corticosteroid-eluting sinus implant</keyword>
  <keyword>chronic rhinosinusitis</keyword>
  <keyword>mometasone furoate</keyword>
  <keyword>polyposis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Nasal Polyps</mesh_term>
    <mesh_term>Polyps</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>
    <ipd_description>No plan</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were enrolled between January 2013 and November 2013 at 18 clinical sites (12 private, 6 academic).</recruitment_details>
      <pre_assignment_details>A total of 100 patients were enrolled and randomized. met final eligibility. There was a 2-week run-in period before screening during which participants were required to use an intranasal corticosteroid spray.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>In-office bilateral sham procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</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="53"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="100"/>
          </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="47.8" spread="12.61"/>
                    <measurement group_id="B2" value="51.6" spread="13.12"/>
                    <measurement group_id="B3" value="49.6" spread="12.93"/>
                  </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="24"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Nasal Obstruction/Congestion Score</title>
        <description>Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in</description>
        <time_frame>90 days</time_frame>
        <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Obstruction/Congestion Score</title>
          <description>Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in</description>
          <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.</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="53"/>
                <count group_id="O2" value="47"/>
              </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="53"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.62" spread="1.180"/>
                    <measurement group_id="O2" value="3.30" spread="1.159"/>
                  </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="52"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.31" spread="1.422"/>
                    <measurement group_id="O2" value="2.62" spread="1.336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="1.465"/>
                    <measurement group_id="O2" value="-0.67" spread="1.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1365</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0505</p_value>
            <p_value_desc>Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects</p_value_desc>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bilateral Polyp Grade</title>
        <description>Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.</description>
        <time_frame>90 days</time_frame>
        <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Bilateral Polyp Grade</title>
          <description>Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.</description>
          <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.</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="53"/>
                <count group_id="O2" value="47"/>
              </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="51"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.90" spread="0.918"/>
                    <measurement group_id="O2" value="4.39" spread="1.448"/>
                  </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="52"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.12" spread="1.162"/>
                    <measurement group_id="O2" value="4.00" spread="1.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.76" spread="0.875"/>
                    <measurement group_id="O2" value="-0.38" spread="0.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0985</p_value>
            <method>ANCOVA</method>
            <method_desc>Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0490</p_value>
            <method>ANOVA</method>
            <method_desc>Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ethmoid Sinus Obstruction</title>
        <description>Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.</description>
        <time_frame>90 days</time_frame>
        <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>S8 Sinus Implant</title>
            <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Ethmoid Sinus Obstruction</title>
          <description>Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.</description>
          <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.</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="53"/>
                <count group_id="O2" value="47"/>
              </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="52"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.59" spread="18.201"/>
                    <measurement group_id="O2" value="62.74" spread="25.673"/>
                  </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="52"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.54" spread="20.140"/>
                    <measurement group_id="O2" value="57.17" spread="28.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.05" spread="19.361"/>
                    <measurement group_id="O2" value="-5.57" spread="18.279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0099</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bilateral Polyp Grade</title>
        <description>Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.</description>
        <time_frame>90 days, 6 months</time_frame>
        <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>S8 Sinus Implant</title>
            <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Bilateral Polyp Grade</title>
          <description>Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.</description>
          <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="47"/>
              </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="53"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.68" spread="0.956"/>
                    <measurement group_id="O2" value="4.32" spread="1.105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>90 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="1.655"/>
                    <measurement group_id="O2" value="4.24" spread="1.667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 90 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" spread="1.680"/>
                    <measurement group_id="O2" value="-0.09" spread="1.203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.96" spread="1.587"/>
                    <measurement group_id="O2" value="4.36" spread="1.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to 6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="1.527"/>
                    <measurement group_id="O2" value="0.02" spread="1.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0162</p_value>
            <p_value_desc>P-value for change from baseline to 90 days not adjusted for multiplicity</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with baseline as a covariate and site and treatment as fixed effects</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0175</p_value>
            <p_value_desc>P-value for change from baseline to 6 months not adjusted for multiplicity</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with baseline as a covariate and site and treatment as fixed effects</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nasal Obstruction Symptom Evaluation (NOSE) Score</title>
        <description>NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.</description>
        <time_frame>6 months</time_frame>
        <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>S8 Sinus Implant</title>
            <description>Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)&#xD;
S8 Sinus Implant: Bilateral in-office placement of S8 sinus implant with 1350 mcg of mometasone furoate and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Bilateral in-office sham procedure in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)&#xD;
Sham procedure: Bilateral in-office sham procedure and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Nasal Obstruction Symptom Evaluation (NOSE) Score</title>
          <description>NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.</description>
          <population>Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.</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="53"/>
                <count group_id="O2" value="47"/>
              </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="53"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.79" spread="26.658"/>
                    <measurement group_id="O2" value="63.19" spread="23.943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.83" spread="24.395"/>
                    <measurement group_id="O2" value="50.67" spread="25.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.58" spread="28.174"/>
                    <measurement group_id="O2" value="-12.22" spread="23.874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0209</p_value>
            <p_value_desc>P-value not adjusted for multiplicity.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)</title>
        <description>To be indicated for RESS, the following criteria had to be met:&#xD;
Continued to use topical intranasal steroids daily;&#xD;
Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use&#xD;
Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and&#xD;
Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade &gt;=2 on at least one side)</description>
        <time_frame>90 days, 6 months</time_frame>
        <population>Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>S8 Sinus Implant</title>
            <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)</title>
          <description>To be indicated for RESS, the following criteria had to be met:&#xD;
Continued to use topical intranasal steroids daily;&#xD;
Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use&#xD;
Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and&#xD;
Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade &gt;=2 on at least one side)</description>
          <population>Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="47"/>
              </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="53"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="47"/>
                  </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="52"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from enrollment though month 6</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>In-office bilateral sham procedure&#xD;
Mometasone furoate nasal spray (200mcg) once daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Chronic Sinusitits</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </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>
    <limitations_and_caveats>Absence of defined medical regimen prior to enrollment&#xD;
Investigators grading polyps and assessing indication for RESS were not blinded&#xD;
Indication for RESS at baseline allowed for 1 sinus side to have polyp grade &gt;=1</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>James Stambaugh, Vice President of Clinical &amp; Medical Affairs</name_or_title>
      <organization>Intersect ENT, Inc.</organization>
      <phone>650-641-2103</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/NCT01732536
org study id: P500-1012
nct id: NCT01732536
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic
      sinusitis patients with recurrent nasal polyps.
RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter
      study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented
      with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy
      of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable
      self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use
      delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The
      coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days,
      with the majority of drug released within 60 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.
measure: Nasal Obstruction/Congestion Score
time frame: 90 days
description: Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in
measure: Bilateral Polyp Grade
time frame: 90 days
description: Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.
measure: Ethmoid Sinus Obstruction
time frame: 90 days
description: Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.
measure: Bilateral Polyp Grade
time frame: 90 days, 6 months
description: Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.
measure: Nasal Obstruction Symptom Evaluation (NOSE) Score
time frame: 6 months
description: NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.
measure: Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
time frame: 90 days, 6 months
description: To be indicated for RESS, the following criteria had to be met:
Continued to use topical intranasal steroids daily;
Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use
Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and
Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)
arm group label: S8 Sinus Implant
arm group type: Experimental
description: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
arm group label: Control
arm group type: Sham Comparator
description: In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
intervention type: Drug
intervention name: S8 Sinus Implant
description: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
arm group label: S8 Sinus Implant
other name: SINUVA (mometasone furoate) sinus implant
intervention type: Procedure
intervention name: Sham procedure
description: In-office bilateral sham procedure
arm group label: Control
intervention type: Drug
intervention name: Mometasone furoate nasal spray
description: Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90
arm group label: Control
arm group label: S8 Sinus Implant
other name: Nasonex Nasal Spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keith D Forwith, MD
role: Principal Investigator
affiliation: Advanced ENT and Allergy
last name: Joseph K Han, MD
role: Principal Investigator
affiliation: Eastern Virginia Medical School Department of Otolaryngology
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country: United States
citation: Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.
PMID: 25266981
citation: Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.
PMID: 26992115
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Nasal Polyps
mesh term: Polyps
mesh term: Mometasone Furoate
sharing ipd: No
ipd description: No plan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Absence of defined medical regimen prior to enrollment
Investigators grading polyps and assessing indication for RESS were not blinded
Indication for RESS at baseline allowed for 1 sinus side to have polyp grade >=1
point of contact: 