Sinopsys Lacrimal Stent Indicated for Sinus Irrigation (SLS)

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

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

Study Overview

• Status: Completed
• Conditions: Ethmoid Sinusitis
• Intervention / Treatment: Device: 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: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Greeley, Colorado, United States, 80634
      • Front Range ENT
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT and Allergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: SLS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT - 20	Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)	18 Weeks
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.	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.	18 Weeks
Safety: Incidence and occurrence of anticipated and unanticipated adverse events	Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.	18 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lund-MacKay CT Scores	Comparison of baseline and 12 weeks	12 Weeks
Lund-Kennedy Nasal Endoscopy Scores	Comparison of baseline and 12 weeks	12 Weeks

Collaborators and Investigators

• Sponsor: Sinopsys Surgical
• Investigators: Study Director: Teena Augustino, Sinopsys Surgical Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (ESTIMATE): November 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Ethmoid Sinusitis
• Other Study ID Numbers: SLS-US-02