Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

Overview

The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

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.

Interventions

  • Device: Sinopsys Lacrimal Stent
    • The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.

Arms, Groups and Cohorts

  • Experimental: Sinopsys Lacrimal Stent
    • The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sinopsys Surgical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Teena Augustino, Study Director, Sinopsys Surgical Inc.

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