Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

Completed · Not applicable

Conditions studied: Chronic Sinusitis

In brief

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 the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).

Key facts

Study ID

NCT00912405

Run by

Intersect ENT

People needed

50

Starts

2009-03-01

Expected to finish

2009-12-01

Last updated by the study team

2015-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central California Ear, Nose Thraot — Fresno, California, United States

Full record on ClinicalTrials.gov

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