<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/NCT02188589</url>
  </required_header>
  <id_info>
    <org_study_id>SPI-NVC-13001</org_study_id>
    <nct_id>NCT02188589</nct_id>
  </id_info>
  <brief_title>Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse</brief_title>
  <official_title>Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spirox, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spirox, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to&#xD;
      severe nasal valve collapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal&#xD;
      Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX&#xD;
      Nasal Implant in subjects with moderate to severe nasal valve collapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant-related Adverse Events</measure>
    <time_frame>6 months</time_frame>
    <description>Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breathing Capacity (NOSE Scores)</measure>
    <time_frame>At baseline and at 6, 12, and 24 months post implant</time_frame>
    <description>Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NOSE Responder Rate</measure>
    <time_frame>At 6, 12, and 24 months post implant</time_frame>
    <description>Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Nasal Valve Collapse</condition>
  <arm_group>
    <arm_group_label>Nasal implant group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bilateral or unilateral INEX nasal implants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>INEX nasal implant</intervention_name>
    <description>Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)</description>
    <arm_group_label>Nasal implant group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligible participants are:&#xD;
&#xD;
          1. Adult patients seeking treatment for nasal obstruction on one or both sides of the&#xD;
             nose who are willing to undergo an office-based or intraoperative nasal implant&#xD;
             procedure in lieu of alternative treatments (ie, surgical repair or use of an external&#xD;
             dilator).&#xD;
&#xD;
          2. Nasal valve collapse (NVC) must be a primary or significant contributor to the&#xD;
             subject's nasal obstruction based on clinical presentation, physical examination and&#xD;
             nasal endoscopy.&#xD;
&#xD;
          3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.&#xD;
&#xD;
        Participants are excluded for the following:&#xD;
&#xD;
          1. Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months&#xD;
             before enrollment.&#xD;
&#xD;
          2. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6&#xD;
             months before enrollment.&#xD;
&#xD;
          3. Recurrent nasal infections.&#xD;
&#xD;
          4. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.&#xD;
&#xD;
          5. Presence of a permanent implant, dilator, or uses an external device in the nasal&#xD;
             area.&#xD;
&#xD;
          6. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or&#xD;
             chemotherapy within 24 months of the study.&#xD;
&#xD;
          7. Significant bleeding disorders.&#xD;
&#xD;
          8. Significant systemic diseases.&#xD;
&#xD;
          9. Currently using nasal oxygen or continuous positive airway pressure (CPAP).&#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>Alexander Berghaus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians - University of Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.</citation>
    <PMID>14990910</PMID>
  </reference>
  <results_reference>
    <citation>San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7. Erratum In: Facial Plast Surg. 2017 Jun;33(3):353-354.</citation>
    <PMID>28388804</PMID>
  </results_reference>
  <results_reference>
    <citation>San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.</citation>
    <PMID>30227454</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <results_first_submitted>June 17, 2016</results_first_submitted>
  <results_first_submitted_qc>August 16, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 10, 2016</results_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Months</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>12 Months</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>24 Months</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.1" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Implant-related Adverse Events</title>
        <description>Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)</description>
          </group>
        </group_list>
        <measure>
          <title>Implant-related Adverse Events</title>
          <description>Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breathing Capacity (NOSE Scores)</title>
        <description>Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).</description>
        <time_frame>At baseline and at 6, 12, and 24 months post implant</time_frame>
        <population>All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)</description>
          </group>
        </group_list>
        <measure>
          <title>Breathing Capacity (NOSE Scores)</title>
          <description>Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).</description>
          <population>All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </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="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.7" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.2" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p&lt;0.05.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NOSE Responder Rate</title>
        <description>Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.</description>
        <time_frame>At 6, 12, and 24 months post implant</time_frame>
        <population>All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Nasal Implant Group</title>
            <description>Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)</description>
          </group>
        </group_list>
        <measure>
          <title>NOSE Responder Rate</title>
          <description>Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.</description>
          <population>All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 24 months post implant</time_frame>
      <desc>Device extrusions/retrievals were counted as serious implant-related adverse events. Otherwise, the standard definition applies.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>Nasal implant: Treatment group may receive unilateral or bilateral nasal implants (maximum of 4, 2 per side)</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="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Nonsurgical implant retrieval</sub_title>
                <description>3/56 total implants placed were retrieved post implantation. Implant retrieval did not require surgical intervention and did not result in any adverse clinical sequelae.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <description>Bronchitis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hernia Repair Procedure</sub_title>
                <description>Hernia repair procedure occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="10" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Normal Bleeding Epistaxis</sub_title>
                <description>Normal bleeding epistaxis occurred during the follow-up period and was not related to the investigational device or the nasal implant procedure.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <description>Includes reports of rhinitis and &quot;common cold&quot;, non-serious and not device-related</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rhinorrhea</sub_title>
                <description>Non-serious and not device-related</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <description>Non-serious and not device-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Non serious and not device-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <description>A non-serious device-related hematoma was observed.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <description>A non-serious device-related observation of inflammation was reported.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Injury by fallen tree</sub_title>
                <description>Non-serious and not device-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Acute hypertension</sub_title>
                <description>Non-serious and not device-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Principal Clinical Research &amp; Publications Manager</name_or_title>
      <organization>Stryker ENT</organization>
      <phone>763-463-1598</phone>
      <email>ellen.omalley@stryker.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/NCT02188589
org study id: SPI-NVC-13001
nct id: NCT02188589
lead sponsor: 
has dmc: No
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to
      severe nasal valve collapse.
This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal
      Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX
      Nasal Implant in subjects with moderate to severe nasal valve collapse.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implant-related Adverse Events
time frame: 6 months
description: Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
measure: Breathing Capacity (NOSE Scores)
time frame: At baseline and at 6, 12, and 24 months post implant
description: Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).
measure: NOSE Responder Rate
time frame: At 6, 12, and 24 months post implant
description: Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.
arm group label: Nasal implant group
arm group type: Experimental
description: Bilateral or unilateral INEX nasal implants
intervention type: Device
intervention name: INEX nasal implant
description: Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
arm group label: Nasal implant group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Berghaus, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians - University of Munich
facility: 
country: Germany
citation: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
PMID: 14990910
citation: San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7. Erratum In: Facial Plast Surg. 2017 Jun;33(3):353-354.
PMID: 28388804
citation: San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.
PMID: 30227454
responsible party type: Sponsor
mesh term: Shock
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 