<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/NCT02240615</url>
  </required_header>
  <id_info>
    <org_study_id>SLS-US-01</org_study_id>
    <nct_id>NCT02240615</nct_id>
  </id_info>
  <brief_title>The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora</brief_title>
  <official_title>The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinopsys Surgical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinopsys Surgical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open label, multi-center, non-randomized study designed to collect initial&#xD;
      clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent&#xD;
      for use during repair of the lacrimal system in patients with functional or obstructive&#xD;
      epiphora.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 10 patients will be enrolled and followed for six months. The primary objective is to&#xD;
      demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during&#xD;
      repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular&#xD;
      pathologies in this patient population. The primary outcome measure for performance is the&#xD;
      relief of epiphora determined by both investigator assessment of stent patency and patient&#xD;
      self-assessment of epiphora symptom improvement compared to baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing.</measure>
    <time_frame>Six Months</time_frame>
    <description>PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of device insertion success</measure>
    <time_frame>Procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of all safety</measure>
    <time_frame>Six Months</time_frame>
    <description>Recording of all safety events that occur in the first six months of treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Epiphora</condition>
  <arm_group>
    <arm_group_label>Sinopsys Lacrimal Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled patients will receive a Sinopsys Lacrimal Stent inserted from the caruncle to the ethmoid sinus. Discharge instructions will include administration of sterile saline and ophthalmic drops as well as assessments for device patency.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sinopsys Lacrimal Stent</intervention_name>
    <description>Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora</description>
    <arm_group_label>Sinopsys Lacrimal Stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically significant functional epiphora for at least three months&#xD;
&#xD;
          -  Keros classification 1 or 2 skull base anatomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Craniofacial deformity&#xD;
&#xD;
          -  Severe inflammatory disease&#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>Harry Ross, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sinopsys Surgical Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teena Augostino</last_name>
    <role>Study Director</role>
    <affiliation>Sinopsys Surgical Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Health Sciences Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Sight</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Specialists</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 11, 2016</last_update_submitted>
  <last_update_submitted_qc>February 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epiphora</keyword>
  <keyword>Lacrimal Stent</keyword>
  <keyword>Lacrimal System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacrimal Apparatus Diseases</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/NCT02240615
org study id: SLS-US-01
nct id: NCT02240615
lead sponsor: 
has dmc: No
Prospective, open label, multi-center, non-randomized study designed to collect initial
      clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent
      for use during repair of the lacrimal system in patients with functional or obstructive
      epiphora.
Up to 10 patients will be enrolled and followed for six months. The primary objective is to
      demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during
      repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular
      pathologies in this patient population. The primary outcome measure for performance is the
      relief of epiphora determined by both investigator assessment of stent patency and patient
      self-assessment of epiphora symptom improvement compared to baseline.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relief of epiphora, determined by both 1) the Investigator assessment of the patency/function of the Sinopsys Lacrimal Stent ( and 2) the subject's self-assessment of tearing.
time frame: Six Months
description: PI self assessment of stent patency and patient self assessment of improvement of epiphora symptoms compared to baseline
measure: Measurement of device insertion success
time frame: Procedural
measure: Evaluation of all safety
time frame: Six Months
description: Recording of all safety events that occur in the first six months of treatment
arm group label: Sinopsys Lacrimal Stent
arm group type: Experimental
description: All enrolled patients will receive a Sinopsys Lacrimal Stent inserted from the caruncle to the ethmoid sinus. Discharge instructions will include administration of sterile saline and ophthalmic drops as well as assessments for device patency.
intervention type: Device
intervention name: Sinopsys Lacrimal Stent
description: Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
arm group label: Sinopsys Lacrimal Stent
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Harry Ross, MD
role: Study Director
affiliation: Sinopsys Surgical Inc.
last name: Teena Augostino
role: Study Director
affiliation: Sinopsys Surgical Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lacrimal Apparatus Diseases