Clinical Evaluation of the Ethmoid Sinus Spacer
Not Applicable
Terminated
- Conditions
- Sinusitis, Chronic Rhinosinusitis
- Interventions
- Device: Ethmoid Sinus Spacer
- Registration Number
- NCT01054703
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Age > 21 years old
- Both male and female
- Ethmoid disease on CT scan
- At least one non-ethmoid sinus requiring treatment
- Failed medical management and symptomatic
Exclusion Criteria
- Previous ethmoid surgery
- Not sufficient room for placement of Spacer
- Patient requires septoplasty
- Has received steroid treatment with in 2 weeks
- Extensive sinonasal osteoneogenesis preventing device placement
- Sinonasal tumors or obstructive lesions
- History of facial trauma that distorts sinus anatomy
- Asthmatic patients with aspirin sensitivity
- Pregnant or lactating females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ethmoid Sinus Spacer placement Ethmoid Sinus Spacer Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
- Primary Outcome Measures
Name Time Method Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant Procedural and 6 weeks post-implant
- Secondary Outcome Measures
Name Time Method Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures 1 wk, 2wk, 4wk, 6wk
Trial Locations
- Locations (1)
Georgia Nasal and Sinus Institute
🇺🇸Savannah, Georgia, United States