<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/NCT03304951</url>
  </required_header>
  <id_info>
    <org_study_id>SLSEU01</org_study_id>
    <nct_id>NCT03304951</nct_id>
  </id_info>
  <brief_title>Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation</brief_title>
  <official_title>Interventioanl Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery</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>
      The primary objective is to evaluate clinical data related to the safety and performance of&#xD;
      the Sinopsys® Lacrimal Stent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the safety and performance of the&#xD;
      Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic&#xD;
      rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic&#xD;
      antibiotic/steroid drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of acute procedural/device success</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Clinical Success at Week 1, 4 and 8 weeks</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores</measure>
    <time_frame>8 Weeks</time_frame>
    <description>Comparison of Endoscopy and CT scores from Baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Ethmoid Sinusitis</condition>
  <arm_group>
    <arm_group_label>Synopsis® Lacrimal Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid sinus access</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sinopsys® Lacrimal Stent</intervention_name>
    <description>The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.</description>
    <arm_group_label>Synopsis® Lacrimal Stent</arm_group_label>
    <other_name>SLS (Sinopsys® Lacrimal Stent)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Investigator has determined that the potential study subject has moderate to severe&#xD;
             chronic rhino sinusitis with ethmoid involvement and has failed medical therapy prior&#xD;
             to enrollment.&#xD;
&#xD;
          -  Age ≥22 years The potential study subject meets the American Academy of&#xD;
             Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria for chronic rhino sinusitis&#xD;
             (Rosenfeld, et al, 2007)&#xD;
&#xD;
          -  12 weeks or longer of two or more o f the following signs and symptoms:&#xD;
&#xD;
               -  Mucopurulent drainage (anterior, posterior or both)&#xD;
&#xD;
               -  Nasal Obstruction (congestion)&#xD;
&#xD;
               -  Facial pain-pressure-fullness, or&#xD;
&#xD;
               -  Decreased sense of smell and Inflammation si documents by one or more of the&#xD;
                  following findings:&#xD;
&#xD;
               -  Purulent (not clear) mucus or edema in the middle meatus or ethmoid region&#xD;
&#xD;
               -  Polyps in nasal cavity or the middle meatus, and/or&#xD;
&#xD;
               -  Radiographic imaging showing inflammation of the paranasal sinuses&#xD;
&#xD;
          -  SNOT-20 total raw score ≥ 41&#xD;
&#xD;
          -  Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros&#xD;
             classification 1or 2 (Gauba, Sleh, Dua, Agarwal, Ell, &amp; Vize, 2006)&#xD;
&#xD;
          -  The potential study subject is capable of understanding and executing written informed&#xD;
             consent (IC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund-Mackay&#xD;
             scoring system&#xD;
&#xD;
          -  Isolated sinus disease evident on Non-Contrast CT scan that would unlikely to respond&#xD;
             to target ethmoid treatment (e.g., isolated sphenoid or frontal disease).&#xD;
&#xD;
          -  Polyposis scored as 3 using the Modified Lund-Kennedy Score as follows:&#xD;
&#xD;
             3 = Polyps completely obstructing the nose&#xD;
&#xD;
          -  Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the&#xD;
             orbit or sinus (i.e. Fess, balloon sinuplasty). Minor procedures such as septoplasty&#xD;
             or turbinectomy are not exclusions.&#xD;
&#xD;
          -  Prior surgical history, physical exam, nasal endoscopy, and /or imaging studies that&#xD;
             suggest significant craniofacial deformity (such as facial anatomic abnormality from&#xD;
             surgical intervention, trauma, and congenital or any other cause thus prohibiting&#xD;
             adequate placement of the Sinopsys® Lacrimal Stent).&#xD;
&#xD;
          -  Presence of a sinonasal encepholocele as determined by Non-Contrast CT scan.&#xD;
&#xD;
          -  Presence of active HEENT infection including acute dacryocystitis, with the exception&#xD;
             of baseline CRS (Chronic Rhinosinusitis) infection.&#xD;
&#xD;
          -  Febrile illness within 2 weeks of procedure and/or active pus from nose.&#xD;
&#xD;
          -  Any sign of active ophthalmic disease, infection or inflammation including the&#xD;
             presence of severe ocular surface inflammatory disease as determined by ophthalmic and&#xD;
             physical exam, which could be exacerbated by the presence of the device.&#xD;
&#xD;
          -  Current use of topical medications for the eye to treat an active ophthalmic disease.&#xD;
&#xD;
          -  Underlying medical condition that, in the opinion of the Investigator, would place the&#xD;
             subject at high risk if PO or IV sedation (MAC or monitored anesthesia care) were used&#xD;
             during the procedure.&#xD;
&#xD;
          -  Known silicone allergy&#xD;
&#xD;
          -  Documented diagnostic history of Cystic Fibrosis&#xD;
&#xD;
          -  Documented history of migraines and/or cluster headaches requiring treatment with&#xD;
             anti-migraine medication.&#xD;
&#xD;
          -  Documented uncontrolled or poorly controlled seasonal or perennial allergies requiring&#xD;
             daily anti-allergy oral, nasal or ophthalmic medications.&#xD;
&#xD;
          -  Tobacco, marijuana and /or e-vape inhaler use either currently or during the last 6&#xD;
             months&#xD;
&#xD;
          -  Documented history of bleeding disorders, for example, von Willebrand's disease or&#xD;
             hemophilia.&#xD;
&#xD;
          -  Inability to stop thrombolytics or other anti-platelet medication prior to procedure&#xD;
             day including but not limited to Coumadin (warfarin) for 5 days, Plavix (clopidogrel)&#xD;
             for 3 days, ASA(aspirin)/NSAIDs/fish oil supplements for 10 days, Xeralta®&#xD;
             (rivaroxaban) for 24 hours.&#xD;
&#xD;
          -  For contact lens wearers, inability to go without contact lenses for at least 10 days&#xD;
             postoperatively.&#xD;
&#xD;
          -  Known use of any investigational ocular or sinusitis drug(s) or devices within 30 days&#xD;
             prior to enrollment.&#xD;
&#xD;
          -  Investigator determination that the potential study subject is unable to comply with&#xD;
             study procedures and /or follow-up, or provided informed consent.&#xD;
&#xD;
          -  Women of childbearing potential who test positive on the study-required urine&#xD;
             pregnancy test and who are unwilling to practice a medically acceptable contraception&#xD;
             regimen from screening through week 8 visit. Women who are documented as&#xD;
             postmenopausal for at least 1 year (&gt; 12 months since last menses) or are surgically&#xD;
             sterilized, do not require testing.&#xD;
&#xD;
          -  Severe co-morbidity or poor general physical/mental health that, in the opinion of the&#xD;
             Investigator, will not allow the subject to be a good study candidate (i.e. other&#xD;
             disease processes, mental capacity, cognitive function, substance abuse, shortened&#xD;
             life expectancy, vulnerable patient population, high surgical risk).&#xD;
&#xD;
          -  Currently involved in another clinical study where that participation may conflict or&#xD;
             interfere with the treatment, follow-up or results of the clinical 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>Vladan Hrabe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles University, Pilsen Czech Republic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charles University Faculty of Medicine</name>
      <address>
        <city>Pilsen</city>
        <zip>30599</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>February 11, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Ethmoid Sinusitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03304951
org study id: SLSEU01
nct id: NCT03304951
lead sponsor: 
has dmc: No
The primary objective is to evaluate clinical data related to the safety and performance of
      the Sinopsys® Lacrimal Stent.
The primary objective of this study is to evaluate the safety and performance of the
      Sinopsys® Lacrimal Stent in the treatment of patients with moderate to severe chronic chronic
      rhinosinusitis via direct ethmoid sinus saline irrigation and delivery of an ophthalmic
      antibiotic/steroid drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Demonstration of acute procedural/device success
time frame: 8 Weeks
description: Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.
measure: Evaluation of Clinical Success at Week 1, 4 and 8 weeks
time frame: 8 Weeks
description: Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.
measure: Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores
time frame: 8 Weeks
description: Comparison of Endoscopy and CT scores from Baseline
arm group label: Synopsis® Lacrimal Stent
arm group type: Experimental
description: The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid sinus access
intervention type: Device
intervention name: Sinopsys® Lacrimal Stent
description: The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.
arm group label: Synopsis® Lacrimal Stent
other name: SLS (Sinopsys® Lacrimal Stent)
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Vladan Hrabe, MD
role: Principal Investigator
affiliation: Charles University, Pilsen Czech Republic
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Ethmoid Sinusitis
sharing ipd: No