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Sinopsys Lacrimal Stent Indicated for Sinus Irrigation (SLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297243
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Sinopsys Surgical

Tracking Information
First Submitted Date  ICMJE November 14, 2014
First Posted Date  ICMJE November 21, 2014
Last Update Posted Date February 12, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • SNOT - 20 [ Time Frame: 18 Weeks ]
    Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)
  • Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage. [ Time Frame: 18 Weeks ]
    Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator.
  • Safety: Incidence and occurrence of anticipated and unanticipated adverse events [ Time Frame: 18 Weeks ]
    Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • Lund-MacKay CT Scores [ Time Frame: 12 Weeks ]
    Comparison of baseline and 12 weeks
  • Lund-Kennedy Nasal Endoscopy Scores [ Time Frame: 12 Weeks ]
    Comparison of baseline and 12 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sinopsys Lacrimal Stent Indicated for Sinus Irrigation
Official Title  ICMJE The Sinopsys Lacrimal Stent Indicated for Sinus Irrigation Via Transcaruncular Ethmoid Sinus Access in Patients With Moderate to Severe Chronic Rhinosinusitis With Ethmoid Sinus Involvement
Brief Summary The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
Detailed Description For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ethmoid Sinusitis
Intervention  ICMJE Device: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Other Name: SLS
Study Arms  ICMJE Experimental: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Intervention: Device: Sinopsys Lacrimal Stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
10
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate medical therapy prior to enrollment
  2. Age ≥ 22 years
  3. The potential study subject meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis 12 weeks or longer of two or more of the following signs and symptoms:

    • Mucopurulent drainage (anterior, posterior, or both)
    • Nasal obstruction (congestion)
    • Facial pain-pressure-fullness, or
    • Decreased sense of smell

    AND inflammation is documented by one or more of the following findings:

    • Purulent (not clear) mucus or edema in the middle meatus or ethmoid region
    • Polyps in nasal cavity or the middle meatus, and/or
    • Radiographic imaging showing inflammation of the paranasal sinuses
  4. SNOT-20 total score ≥ 41
  5. CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
  6. CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.

Exclusion Criteria:

  1. Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
  2. Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
  3. Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
  4. Prior ocular and/or sinus surgery for CRS
  5. CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
  6. Prior surgical history, physical exam, nasal endoscopy and/or imaging studies suggest significant distortion of the craniofacial anatomy thus prohibiting adequate placement of the SLS
  7. Presence of a sinonasal encepholocele as determined by CT scan
  8. Presence of active HEENT infection including acute dacryocystitis
  9. Febrile illness within 2 weeks and/or active pus from nose
  10. Any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease or signs and symptoms of "dry eye disease" as determined by physical exam which could be exacerbated by the presence of the device
  11. Current use of topical medications for the eye to treat an active ophthalmic disease
  12. HbA1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02297243
Other Study ID Numbers  ICMJE SLS-US-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sinopsys Surgical
Study Sponsor  ICMJE Sinopsys Surgical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teena Augustino Sinopsys Surgical Inc.
PRS Account Sinopsys Surgical
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP