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Sinopsys Lacrimal Stent Indicated for Sinus Irrigation (SLS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02297243
First Posted: November 21, 2014
Last Update Posted: February 12, 2016
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.
Information provided by (Responsible Party):
Sinopsys Surgical
  Purpose
The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

Condition Intervention Phase
Ethmoid Sinusitis Device: Sinopsys Lacrimal Stent Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sinopsys Surgical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 9
Study Start Date: March 2015
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Device: Sinopsys Lacrimal Stent
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Other Name: SLS

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297243


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Front Range ENT
Greeley, Colorado, United States, 80634
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
Sponsors and Collaborators
Sinopsys Surgical
Investigators
Study Director: Teena Augustino Sinopsys Surgical Inc.
  More Information

Responsible Party: Sinopsys Surgical
ClinicalTrials.gov Identifier: NCT02297243     History of Changes
Other Study ID Numbers: SLS-US-02
First Submitted: November 14, 2014
First Posted: November 21, 2014
Last Update Posted: February 12, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Sinusitis
Ethmoid Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases