Status:
COMPLETED
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Lead Sponsor:
Intersect ENT
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for ...
Eligibility Criteria
Inclusion
- Patient is 18 years of age or older
- Patient has a diagnosis of chronic sinusitis
- Patient has a clinical indication for and has consented to FESS
- Patient CT scan confirms CS diagnosis within 6 months of procedure
- CT sacn confirms presence of disease in ethmoid sinus(es)
- Planned FESS includes unilateral or bilateral total ethmoidectomy
Exclusion
- Immune deficiency (IGG subclass deficiency or IGA deficiency)
- Oral-steroid dependent COPD, asthma or other condition
- Clinical evidence of acute bacterial sinusitis
- History or diagnosis of glaucoma or ocular hypertension
- Clinical evidence or suspicion of invasive fungal sinusitis
- Evidence of disease or condition expected to compromise survival or ability to complete follow-up
- Known history of allergy or intolerance to corticosteroids
- History of insulin dependent diabetes
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00912405
Start Date
March 1 2009
End Date
December 1 2009
Last Update
April 20 2015
Active Locations (1)
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1
Central California Ear, Nose Thraot
Fresno, California, United States