Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide

Not Applicable

Completed

Brief Summary: Study Design:

A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects age 17 years or older
Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)

Exclusion Criteria

Age < 17 years old
History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
Adequate anatomical distances for treatment
Patient received oral steroid treatment within two weeks prior to day of surgery
Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
Sinonasal tumors or obstructive lesions
History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
Contracted/underdeveloped ethmoid sinus
Dehiscent lamina orbitalis
Previous ethmoid surgery
Ethmoid mucocele
Extensive Nasal Polyps
Asthmatic patients with aspirin sensitivity
Pregnant or lactating females

Arm && Interventions

Group	Intervention	Description
Stratus Microflow Ethmoid Spacer	Stratus Microflow Ethmoid Spacer	Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.

Primary Outcome Measures

Name	Time	Method
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.	10 weeks post-procedure	The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg	10 weeks post-procedure	Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of \> 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)	10 weeks post surgery	The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline	10 weeks	The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.