Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (DELIVER)
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 Kenalog-40, over a period of 28 days.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (DELIVER)|
- Number of adverse events [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: Yes ]
- Change in Lund-MacKay CT score [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: No ]
- Change in best corrected visual acuity (BCVA) [ Time Frame: 10 weeks post surgery ] [ Designated as safety issue: Yes ]
- Change in intra-ocular pressure (IOP) [ Time Frame: 10 weeks post-procedure ] [ Designated as safety issue: Yes ]
- Change in mean sino-nasal outcome test-20 (SNOT-20; quality of life) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Stratus Microflow Ethmoid Spacer
Temporary implantation of Ethmoid spacer with Kenalog-40 for 28 days.
Device: Stratus Microflow Ethmoid Spacer
The Spacer is inserted surgically into the ethmoid complex through the use of a Sinus Access System, consisting of a sheath and needle. It is retained in the Ethmoid complex through the use of flexible anchoring wings. The surgeon has the option of suturing the device inside of the nose for additional retention, if desired.
In this protocol, Kenalog-40 (triamcinolone acetonide) will be administered into the Spacer instead of saline. The perforated membrane will then allow the Kenalog-40 to be released over a period of 28 days into the surrounding tissue to combat inflammation in a local, direct, and slow-release fashion. At the end of the time period, the device can be removed with standard instrumentation, during a follow-up office visit.
Other Name: Ethmoid Spacer