Status:
COMPLETED
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Acclarent
Conditions:
Sinusitis
Eligibility:
All Genders
17+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00791934
Start Date
August 1 2008
End Date
November 1 2011
Last Update
August 6 2024
Active Locations (1)
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1
Lahey Clinic
Burlington, Massachusetts, United States, 01805