<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/NCT03036735</url>
  </required_header>
  <id_info>
    <org_study_id>00723</org_study_id>
    <nct_id>NCT03036735</nct_id>
  </id_info>
  <brief_title>Rates of Middle Meatus Synechiae Formation Post ESS</brief_title>
  <official_title>Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Steward St. Elizabeth's Medical Center of Boston, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SinuSys Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Steward St. Elizabeth's Medical Center of Boston, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate if addition of the steroid to the spacer / stent will&#xD;
      improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to evaluate basic device usability and confirm safety and effectiveness&#xD;
      of the Restora Steroid Eluting spacer compared to a Silastic spacer.&#xD;
&#xD;
      At the completion of their procedure, patients undergoing ESS will receive one steroid&#xD;
      eluting spacer placed into the surgical site on one side, and one spacer without drug placed&#xD;
      on the other side. Patients will return for standard post-op visits. Between post-op day 6&#xD;
      and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to&#xD;
      evaluate the surgical sites with respect to healing, scarring, infection, degree of&#xD;
      inflammation, polyp formation, and the need for secondary intervention. Data from the two&#xD;
      sides will be compared to determine if there is a benefit derived from the spacer with&#xD;
      steroid vs the one without.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor withdrew funds&#xD;
  </why_stopped>
  <start_date type="Actual">April 5, 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">April 5, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects undergoing endoscopic sinus surgery (ESS) will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without steroid placed on the other side.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>At the end of surgery, the Surgery Fellow will insert either the Drug Eluting Spacer or the Silastic spacer into each side of the subject's nose. The subject will receive one of each spacer. The fellow will record which spacer was placed on which side using a special coding system to keep this information private. This maintains the blinding for the primary surgeon/outcome assessor and subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery ),&quot; as Accurate and Appropriate).</measure>
    <time_frame>35 to 90days</time_frame>
    <description>Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Sinusitis</condition>
  <arm_group>
    <arm_group_label>Steroid Eluting Spacer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.&#xD;
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>steroid eluting spacer</intervention_name>
    <description>The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.</description>
    <arm_group_label>Steroid Eluting Spacer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 75 years&#xD;
&#xD;
          2. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines&#xD;
&#xD;
          3. Patients who need to undergo primary bilateral complete endoscopic sinus surgery&#xD;
&#xD;
          4. Subject has the ability to follow the study instructions, is willing to be available&#xD;
             on the specific required study visit days, and is willing to complete all study visit&#xD;
             procedures and assessments&#xD;
&#xD;
          5. Subject must understand the research nature of this study and sign an informed consent&#xD;
             prior to the performance of any study-specific procedure or assessment&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subject is pregnant or breast feeding&#xD;
&#xD;
          2. Patients with sino-nasal tumors&#xD;
&#xD;
          3. Patients solely undergoing nasal septal reconstruction&#xD;
&#xD;
          4. Patients with previous history of endoscopic sinus surgery&#xD;
&#xD;
          5. Cystic fibrosis or syndromic patients&#xD;
&#xD;
          6. Patients with autoimmune diseases&#xD;
&#xD;
          7. Patients who have taken oral steroids less than 30 days prior to surgery&#xD;
&#xD;
          8. Patients with a history or diagnosis of glaucoma or ocular hypertension&#xD;
&#xD;
          9. Any other circumstance or condition that in the Investigator's opinion causes the&#xD;
             subject to be an inappropriate candidate for participating in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>May 4, 2015</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>April 19, 2018</results_first_submitted>
  <results_first_submitted_qc>October 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2018</results_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Steward St. Elizabeth's Medical Center of Boston, Inc.</investigator_affiliation>
    <investigator_full_name>Peter Catalano</investigator_full_name>
    <investigator_title>Director otolaryngology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Study was terminated prematurely</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Drug Eluding Spacer</title>
          <description>Restora Mometasone Furate spacer</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Drug Eluding Spacer</title>
          <description>nasal drug eluding spacer</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery ),&quot; as Accurate and Appropriate).</title>
        <description>Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.</description>
        <time_frame>35 to 90days</time_frame>
        <population>Study was terminated , funds withdrawn. No data was collected or analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Drug Eluding Spacer</title>
            <description>nasal drug eluding spacer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery ),&quot; as Accurate and Appropriate).</title>
          <description>Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.</description>
          <population>Study was terminated , funds withdrawn. No data was collected or analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>study was terminated and funds with drawn. No data was obtained.</desc>
      <group_list>
        <group group_id="E1">
          <title>Steroid Eluting Spacer</title>
          <description>Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.&#xD;
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.&#xD;
steroid eluting spacer: The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Study was terminated for lack of funds</sub_title>
                <description>Study was terminated prematurely for lack of funds</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="0"/>
              </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>Dr Peter Catalano</name_or_title>
      <organization>Steward Health Care</organization>
      <phone>617-789-5004 ext 5004</phone>
      <email>peter.catalano@steward.org</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/NCT03036735
org study id: 00723
nct id: NCT03036735
lead sponsor: 
collaborator: 
has dmc: No
The study is designed to evaluate if addition of the steroid to the spacer / stent will
      improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.
The study is designed to evaluate basic device usability and confirm safety and effectiveness
      of the Restora Steroid Eluting spacer compared to a Silastic spacer.

      At the completion of their procedure, patients undergoing ESS will receive one steroid
      eluting spacer placed into the surgical site on one side, and one spacer without drug placed
      on the other side. Patients will return for standard post-op visits. Between post-op day 6
      and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to
      evaluate the surgical sites with respect to healing, scarring, infection, degree of
      inflammation, polyp formation, and the need for secondary intervention. Data from the two
      sides will be compared to determine if there is a benefit derived from the spacer with
      steroid vs the one without.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects undergoing endoscopic sinus surgery (ESS) will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without steroid placed on the other side.
primary purpose: Treatment
masking: None (Open Label)
masking description: At the end of surgery, the Surgery Fellow will insert either the Drug Eluting Spacer or the Silastic spacer into each side of the subject's nose. The subject will receive one of each spacer. The fellow will record which spacer was placed on which side using a special coding system to keep this information private. This maintains the blinding for the primary surgeon/outcome assessor and subject.
measure: Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).
time frame: 35 to 90days
description: Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.
arm group label: Steroid Eluting Spacer
arm group type: Experimental
description: Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side.
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
intervention type: Device
intervention name: steroid eluting spacer
description: The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
arm group label: Steroid Eluting Spacer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
investigator full name: Peter Catalano
investigator title: Director otolaryngology
mesh term: Sinusitis
sharing ipd: Yes
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 