<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/NCT03290300</url>
  </required_header>
  <id_info>
    <org_study_id>TP465</org_study_id>
    <nct_id>NCT03290300</nct_id>
  </id_info>
  <brief_title>Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device</brief_title>
  <official_title>A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aerin Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aerin Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment&#xD;
      with the Aerin Vivaer Stylus&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, multi-center follow-up study to collect long term&#xD;
      quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical&#xD;
      TP258 study &quot;A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal&#xD;
      Airway Obstruction Using the Aerin Medical Device&quot;. The TP258 study followed subjects out to&#xD;
      26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months&#xD;
      post-procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">July 9, 2022</completion_date>
  <primary_completion_date type="Actual">July 9, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline NOSE Score</measure>
    <time_frame>Baseline, 12, 18, 24 months post-procedure</time_frame>
    <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline NOSE Score - Long Term Extended Follow-up</measure>
    <time_frame>Update to include Extended Follow up to 36-, 48- months post-procedure</time_frame>
    <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items</measure>
    <time_frame>12, 18, 24 months post-procedure</time_frame>
    <description>This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered &quot;agree or agree strongly&quot; when prompted with &quot;Compared to before I had the Aerin Medical Nasal Procedure, I have experienced...&quot; were considered to have a positive response. For questions 15-18, those who answered &quot;rarely/very rarely/never&quot; when prompted with &quot;Compared to before you had the procedure, how often did you suffer from the following conditions?...&quot; were considered to have a positive response. For questions 19-21, those who answered &quot;less or much less frequently&quot; when prompted with &quot;Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?...&quot; were considered to have a positive response.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Nasal Obstruction</condition>
  <arm_group>
    <arm_group_label>Long-Term Study Subjects</arm_group_label>
    <description>This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vivaer Stylus</intervention_name>
    <description>Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus</description>
    <arm_group_label>Long-Term Study Subjects</arm_group_label>
    <other_name>Aerin Medical Device</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects in this study will all have completed participation in the TP 258 Nasal&#xD;
        Obstruction study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received nasal obstruction treatment in Aerin Study TP 258&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate in this long-term study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Wolf, MD</last_name>
    <role>Study Director</role>
    <affiliation>Aerin Medical</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ofer Jacobowitz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ENT and Allergy Associates, Middletown, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central California Clinical Research</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado ENT and Allergy</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates, LLP</name>
      <address>
        <city>Oradell</city>
        <state>New Jersey</state>
        <zip>07649</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates, LLP</name>
      <address>
        <city>Bayside</city>
        <state>New York</state>
        <zip>11360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates, LLP</name>
      <address>
        <city>Middletown</city>
        <state>New York</state>
        <zip>10941</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT and Allergy Associates, LLP</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Ear, Nose and 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>Ear, Nose and Throat Associates of Texas</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>July 4, 2019</results_first_submitted>
  <results_first_submitted_qc>July 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 19, 2019</results_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nasal valve</keyword>
  <keyword>Nasal airway obstruction</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</mesh_term>
    <mesh_term>Nasal Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03290300/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03290300/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Long-Term Study Subjects</title>
          <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study (NCT02914236), who consented to continue to provide quality of life data.&#xD;
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Long-Term Study Subjects</title>
          <description>This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.&#xD;
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </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="51.7" spread="12.8"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline NOSE Score</title>
          <description>The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increases symptoms/symptom severity.&#xD;
Each subject's baseline score was recorded at the beginning of the previous study, TP258.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.8" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>26-week NOSE Score (end of previous study)</title>
          <description>The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increases symptoms/symptom severity.&#xD;
The 26-week NOSE Score was the last score recorded for each subject at the end of the previous study, TP258.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.9" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Change in NOSE score from baseline to 26 weeks</title>
          <description>The Nasal Obstruction Symptom Evaluation score is used to assess severity of nasal obstruction symptoms. The NOSE scale ranges from 0 to 100. A positive number reported for the change from baseline indicates an improved outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.9" spread="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>26-week responder</title>
          <description>A &quot;responder&quot; for the prior study, TP258, was defined as a subject having at least a 15-point improvement in NOSE score (NOSE score described previously). The 39 subjects enrolled in this extension study were categorized as responders or nonresponders based on the change in NOSE score between baseline and the final 26-week follow-up of the previous study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline NOSE Score</title>
        <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
        <time_frame>Baseline, 12, 18, 24 months post-procedure</time_frame>
        <population>The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Long-Term Study Subjects - 12 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and were enrolled in this study within the 12-month post-procedure window.</description>
          </group>
          <group group_id="O2">
            <title>Long-Term Study Subjects - 18 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 18-month post-procedure window.</description>
          </group>
          <group group_id="O3">
            <title>Long-Term Study Subjects - 24 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 24-month post-procedure window.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline NOSE Score</title>
          <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
          <population>The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up.</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="36"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3" spread="25.2"/>
                    <measurement group_id="O2" value="48.1" spread="30.2"/>
                    <measurement group_id="O3" value="53.5" spread="24.6"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>The pre-specified threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>Repeated measures ANOVA with multiple comparisons to baseline</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline NOSE Score - Long Term Extended Follow-up</title>
        <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
        <time_frame>Update to include Extended Follow up to 36-, 48- months post-procedure</time_frame>
        <population>Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months.</population>
        <group_list>
          <group group_id="O1">
            <title>36 Month</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 48-month post-procedure window.</description>
          </group>
          <group group_id="O2">
            <title>Long-Term Study Subjects - 48 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data and provided data within the 48-month post-procedure window.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline NOSE Score - Long Term Extended Follow-up</title>
          <description>Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.</description>
          <population>Of the 49 patients in the initial study,39 agreed to participate in follow-up through 24 months.</population>
          <units>score 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="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" spread="21.4"/>
                    <measurement group_id="O2" value="25.7" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items</title>
        <description>This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered &quot;agree or agree strongly&quot; when prompted with &quot;Compared to before I had the Aerin Medical Nasal Procedure, I have experienced...&quot; were considered to have a positive response. For questions 15-18, those who answered &quot;rarely/very rarely/never&quot; when prompted with &quot;Compared to before you had the procedure, how often did you suffer from the following conditions?...&quot; were considered to have a positive response. For questions 19-21, those who answered &quot;less or much less frequently&quot; when prompted with &quot;Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?...&quot; were considered to have a positive response.</description>
        <time_frame>12, 18, 24 months post-procedure</time_frame>
        <population>Data missing for some questions not answered by subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Long-Term Study Subjects - 12 Month</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 12 months post-procedure</description>
          </group>
          <group group_id="O2">
            <title>Long-Term Study Subjects - 18 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 18 months post-procedure</description>
          </group>
          <group group_id="O3">
            <title>Long-Term Study Subjects - 24 Month Data</title>
            <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to provide quality of life data and completed questionnaires 24 months post-procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items</title>
          <description>This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered &quot;agree or agree strongly&quot; when prompted with &quot;Compared to before I had the Aerin Medical Nasal Procedure, I have experienced...&quot; were considered to have a positive response. For questions 15-18, those who answered &quot;rarely/very rarely/never&quot; when prompted with &quot;Compared to before you had the procedure, how often did you suffer from the following conditions?...&quot; were considered to have a positive response. For questions 19-21, those who answered &quot;less or much less frequently&quot; when prompted with &quot;Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?...&quot; were considered to have a positive response.</description>
          <population>Data missing for some questions not answered by subjects.</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="36"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q1: Less difficulty falling asleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2: Less waking up at night</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3: Better sleep throughout the night</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4: Waking up feeling rested</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5: Less fatigue during the day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q6: Increased productivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q7: Increased energy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q8: Increased ability to focus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="38"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q9: Increased sense of overall well-being</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q10: Less feelings of frustration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q11: Less feelings of sadness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q12: Less feelings of embarrassment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q13:Missing fewer activites with family/friends</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q14: Missing fewer days at work</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q15: Headaches</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q16: Sinus infections</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q17: Sore throat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q18: Post nasal drip</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q19: Oral medications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q20: Nasal sprays</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q21: Nasal breathing strips</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="39"/>
                    <count group_id="O3" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Between 1 and 2 years post-procedure</time_frame>
      <desc>Physician's office communicated with the subject either in person or by phone at each follow-up point.</desc>
      <group_list>
        <group group_id="E1">
          <title>Long-Term Study Subjects</title>
          <description>This cohort consisted of subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consented to continue to provide quality of life data.&#xD;
Vivaer Stylus: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus</description>
        </group>
      </group_list>
      <serious_events>
        <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="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </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>First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>use of a single-arm design without randomized control, no control of medication usage, and significant patient attrition relative to the primary study. Two nonparticipants were known to have undergone subsequent surgery for nasal obstruction and it is possible that the effectiveness declined in the extended follow-up nonparticipants, although participants and non-participants had similar baseline characteristics and both groups experienced robust NOSE score reductions at 6months.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Scott Wolf, M.D.; Chief Medical Officer</name_or_title>
      <organization>Aerin Medical, Inc.</organization>
      <phone>650-597-0111</phone>
      <email>swolf@aerinmedical.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/NCT03290300
org study id: TP465
nct id: NCT03290300
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment
      with the Aerin Vivaer Stylus
This is a prospective, non-randomized, multi-center follow-up study to collect long term
      quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical
      TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal
      Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to
      26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months
      post-procedure.
observational model: Cohort
time perspective: Prospective
measure: Change From Baseline NOSE Score
time frame: Baseline, 12, 18, 24 months post-procedure
description: Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
measure: Change From Baseline NOSE Score - Long Term Extended Follow-up
time frame: Update to include Extended Follow up to 36-, 48- months post-procedure
description: Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.
measure: Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
time frame: 12, 18, 24 months post-procedure
description: This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered "agree or agree strongly" when prompted with "Compared to before I had the Aerin Medical Nasal Procedure, I have experienced..." were considered to have a positive response. For questions 15-18, those who answered "rarely/very rarely/never" when prompted with "Compared to before you had the procedure, how often did you suffer from the following conditions?..." were considered to have a positive response. For questions 19-21, those who answered "less or much less frequently" when prompted with "Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?..." were considered to have a positive response.
arm group label: Long-Term Study Subjects
description: This cohort will consist of all subjects who were treated with the Vivaer Stylus in the 50-subject TP258 interventional study, who consent to continue to provide quality of life data.
intervention type: Device
intervention name: Vivaer Stylus
description: Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
arm group label: Long-Term Study Subjects
other name: Aerin Medical Device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Wolf, MD
role: Study Director
affiliation: Aerin Medical
last name: Ofer Jacobowitz, MD, PhD
role: Principal Investigator
affiliation: ENT and Allergy Associates, Middletown, NY
facility: 
facility: 
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facility: 
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Airway Obstruction
mesh term: Nasal Obstruction
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: use of a single-arm design without randomized control, no control of medication usage, and significant patient attrition relative to the primary study. Two nonparticipants were known to have undergone subsequent surgery for nasal obstruction and it is possible that the effectiveness declined in the extended follow-up nonparticipants, although participants and non-participants had similar baseline characteristics and both groups experienced robust NOSE score reductions at 6months.
point of contact: 