<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/NCT01733667</url>
  </required_header>
  <id_info>
    <org_study_id>CSA2011-01</org_study_id>
    <nct_id>NCT01733667</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery</brief_title>
  <acronym>MISTY</acronym>
  <official_title>A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ENTrigue Surgical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ENTrigue Surgical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack&#xD;
      after FESS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MediENT is designed to minimize lateralization of the middle turbinate, which can cause&#xD;
      scarring and obstruction of key sinus openings after endoscopic sinus surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Miller synechia score at 8 weeks</measure>
    <time_frame>8 weeks post endoscopic sinus surgery</time_frame>
    <description>Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Miller Score at 4 &amp; 8 weeks</measure>
    <time_frame>4 &amp; 8 weeks post endoscopic sinus surgery</time_frame>
    <description>Miller synechia score at 4 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 4 weeks judged by an independent evaluator)&#xD;
Total mean Miller score at 8 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Synechia</condition>
  <arm_group>
    <arm_group_label>MediENT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Right or left sinus cavity where MediENT will be place after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MeroPack</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MediENT</intervention_name>
    <description>MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT</description>
    <arm_group_label>MediENT</arm_group_label>
    <other_name>MeroPack</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MeroPack</intervention_name>
    <description>MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT</description>
    <arm_group_label>MeroPack</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is between the ages of 18 and 65 years&#xD;
&#xD;
          2. Subject scheduled to undergo bilateral endoscopic sinus surgery&#xD;
&#xD;
          3. Subject signs IRB-approved informed consent form&#xD;
&#xD;
          4. Subject agrees to comply with all study-related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of removal of one or both middle turbinates&#xD;
&#xD;
          2. Significant sinonasal polyps&#xD;
&#xD;
          3. Presence of marked septal asymmetry&#xD;
&#xD;
          4. Presence of significant concha bullosa, which requires surgical excision&#xD;
&#xD;
          5. Presence of non-viable tissue at the implantation site&#xD;
&#xD;
          6. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's&#xD;
             granulomatosis&#xD;
&#xD;
          7. Known or suspected allergy to device components&#xD;
&#xD;
          8. Participating in another clinical trial which could affect the healing of the middle&#xD;
             turbinate&#xD;
&#xD;
          9. Uncontrolled diabetes&#xD;
&#xD;
         10. Known or suspected use of illicit drugs&#xD;
&#xD;
         11. Known or suspected alcoholism&#xD;
&#xD;
         12. Other medical illness that could prevent follow-up or increase the risk of surgery&#xD;
&#xD;
         13. Pregnant or unwilling to take pregnancy prevention measures&#xD;
&#xD;
         14. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Central California ENT Medical Group</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado ENT &amp; Allergy</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced ENT and Allergy</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENT Associates of Texas</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ear, Nose &amp; Throat Clinics of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>June 3, 2013</last_update_submitted>
  <last_update_submitted_qc>June 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>synechia</keyword>
  <keyword>Fess</keyword>
  <keyword>sinus surgery</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01733667
org study id: CSA2011-01
nct id: NCT01733667
lead sponsor: 
has dmc: No
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack
      after FESS.
MediENT is designed to minimize lateralization of the middle turbinate, which can cause
      scarring and obstruction of key sinus openings after endoscopic sinus surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Miller synechia score at 8 weeks
time frame: 8 weeks post endoscopic sinus surgery
description: Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)
measure: Miller Score at 4 & 8 weeks
time frame: 4 & 8 weeks post endoscopic sinus surgery
description: Miller synechia score at 4 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 4 weeks judged by an independent evaluator)
Total mean Miller score at 8 weeks
arm group label: MediENT
arm group type: Experimental
description: Right or left sinus cavity where MediENT will be place after randomization.
arm group label: MeroPack
arm group type: Active Comparator
description: Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.
intervention type: Device
intervention name: MediENT
description: MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
arm group label: MediENT
other name: MeroPack
intervention type: Device
intervention name: MeroPack
description: MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
arm group label: MeroPack
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor