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

Study Overview
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Brief Summary
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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).

Official Title
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A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Steroid-Eluting Sinexus Intranasal Splint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sinexus Intranasal Splint<br>Patient receives a drug-coated intranasal splint | Device: Steroid-Eluting Sinexus Intranasal Splint<br>* Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) |  | 30 days | 
| Device Placement Success Rate | A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses. | At the time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities | Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified. | Baseline and 30 days | 
| Number of Sinuses With Significant Post-operative Adhesion Formation | Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)