NCT00791934

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DEVICE	Stratus Microflow Ethmoid Spacer	The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-11-17
• Last updated: 2024-08-06
• Results posted: 2014-07-14

Locations

1 site across 1 country: United States