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

Intersect ENT

Status

Completed

Conditions

Chronic Sinusitis

Treatments

Device: Steroid-Eluting Sinexus Intranasal Splint

Study type

Interventional

Funder types

Industry

Identifiers

NCT00912405

P500-0209

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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