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

Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)

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.

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