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

Integra LifeSciences

Status: Completed

Conditions: Sinusitis

Treatments: Device: Stratus Microflow Ethmoid Spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791934

CPR005003

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Stratus Microflow Ethmoid Spacer

Experimental group

Description:

Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days.

Treatment:

Device: Stratus Microflow Ethmoid Spacer