<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/NCT03793218</url>
  </required_header>
  <id_info>
    <org_study_id>20859</org_study_id>
    <nct_id>NCT03793218</nct_id>
  </id_info>
  <brief_title>Alar Batten Graft vs Latera for Nasal Valve Collapse</brief_title>
  <official_title>A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Portland VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist&#xD;
      and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction,&#xD;
      with more easily addressed pathologies such as posterior septal deviation and inferior&#xD;
      turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly&#xD;
      dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon.&#xD;
      Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage&#xD;
      grafting, with alar batten grafting being the most commonly used method to provide support to&#xD;
      the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic&#xD;
      acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal&#xD;
      obstruction. There are several proposed advantages of the implant over traditional operative&#xD;
      techniques, namely the ease of endonasal insertion, which can be performed in the outpatient&#xD;
      clinic setting. Preliminary investigations demonstrate subjective improvement in nasal&#xD;
      obstruction with use of the implant, however, there has been no direct comparison with&#xD;
      traditional techniques utilizing cartilage grafting.&#xD;
&#xD;
      This study is being done at both UVa and in Oregon. This prospective study will randomize&#xD;
      patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of&#xD;
      two groups undergoing treatment with either endonasal batten grafting or the absorbable&#xD;
      Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed&#xD;
      with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom&#xD;
      Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the&#xD;
      groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy&#xD;
      of both techniques. Subjects will be blinded to the surgical intervention they receive.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">November 7, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 7, 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>12 Month NOSE Score</measure>
    <time_frame>12 months</time_frame>
    <description>Mean change in Nose score at 12 month post-op visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 Month NOSE Score</measure>
    <time_frame>1 month</time_frame>
    <description>Mean change in Nose score at 1 month post-op visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Month NOSE Score</measure>
    <time_frame>6 months</time_frame>
    <description>Mean change in Nose score at 6 month post-op visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 Month NOSE Score</measure>
    <time_frame>24 months</time_frame>
    <description>Mean change in Nose score at 24 month post-op visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Nasal Valve Incompetence</condition>
  <arm_group>
    <arm_group_label>Latera Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alar Batten Graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This study seeks to compare a &quot;gold standard&quot; functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Latera Device</intervention_name>
    <description>This study seeks to compare a &quot;gold standard&quot; functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant</description>
    <arm_group_label>Latera Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Alar Batten Graft</intervention_name>
    <description>This study seeks to compare a &quot;gold standard&quot; functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant</description>
    <arm_group_label>Alar Batten Graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented physical exam findings of septal deviation&#xD;
&#xD;
          -  Bilateral nasal sidewall collapse on inspiration&#xD;
&#xD;
          -  Subjective improvement in nasal obstruction with use of the modified Cottle maneuver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior septorhinoplasty&#xD;
&#xD;
          -  Obvious trauma to the nose causing nasal obstruction&#xD;
&#xD;
          -  Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis&#xD;
&#xD;
          -  Patients using chronic topical nasal decongestants or illicit intranasal drug use&#xD;
&#xD;
          -  Prisoners, cognitively impaired, non-English speaking subjects&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>John J Christophel, MD, MPH</last_name>
    <phone>434-243-9391</phone>
    <email>JJC3Y@hscmail.mcc.virginia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Dougherty, BA</last_name>
    <email>mid5kb@virginia.edu</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>John Christophel, MD</investigator_full_name>
    <investigator_title>Associate Professor of Otolaryngology- Head and Neck Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <!-- 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/NCT03793218
org study id: 20859
nct id: NCT03793218
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist
      and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction,
      with more easily addressed pathologies such as posterior septal deviation and inferior
      turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly
      dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon.
      Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage
      grafting, with alar batten grafting being the most commonly used method to provide support to
      the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic
      acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal
      obstruction. There are several proposed advantages of the implant over traditional operative
      techniques, namely the ease of endonasal insertion, which can be performed in the outpatient
      clinic setting. Preliminary investigations demonstrate subjective improvement in nasal
      obstruction with use of the implant, however, there has been no direct comparison with
      traditional techniques utilizing cartilage grafting.

      This study is being done at both UVa and in Oregon. This prospective study will randomize
      patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of
      two groups undergoing treatment with either endonasal batten grafting or the absorbable
      Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed
      with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom
      Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the
      groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy
      of both techniques. Subjects will be blinded to the surgical intervention they receive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 12 Month NOSE Score
time frame: 12 months
description: Mean change in Nose score at 12 month post-op visit
measure: 1 Month NOSE Score
time frame: 1 month
description: Mean change in Nose score at 1 month post-op visit
measure: 6 Month NOSE Score
time frame: 6 months
description: Mean change in Nose score at 6 month post-op visit
measure: 24 Month NOSE Score
time frame: 24 months
description: Mean change in Nose score at 24 month post-op visit
arm group label: Latera Device
arm group type: Experimental
description: The LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period.
arm group label: Alar Batten Graft
arm group type: Active Comparator
description: This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
intervention type: Device
intervention name: Latera Device
description: This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
arm group label: Latera Device
intervention type: Procedure
intervention name: Alar Batten Graft
description: This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
arm group label: Alar Batten Graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John J Christophel, MD, MPH
phone: 434-243-9391
email: JJC3Y@hscmail.mcc.virginia.edu
last name: Michael Dougherty, BA
email: mid5kb@virginia.edu
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: John Christophel, MD
investigator title: Associate Professor of Otolaryngology- Head and Neck Surgery
mesh term: Shock