Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

Ethmoid Sinusitis Clinical Trial

— SLS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297243
• Other study ID #: SLS-US-02
• Status: Completed
• Phase: Phase 0
• First received: November 14, 2014
• Last updated: February 11, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Sinopsys Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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 in?ammation 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ethmoid Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Front Range ENT	Greeley	Colorado
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sinopsys Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Lund-MacKay CT Scores	Comparison of baseline and 12 weeks	12 Weeks	Yes
Secondary	Lund-Kennedy Nasal Endoscopy Scores	Comparison of baseline and 12 weeks	12 Weeks	Yes