A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

Detailed Description
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This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.

Official Title
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A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: non-coated Intranasal Splint
* Device: 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 bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration. Patient has a clinical indication for and has consented to bilateral FESS. CRS diagnosis documented by CT scan within 60 days of the procedure. Patient has minimal total CT stage (Lund-Mackay method) of 6. Patient has bilateral disease defined as minimal CT stage per side of ≥3. Exclusion Criteria: Oral-Steroid dependent COPD, asthma or other condition. Immune deficiency (IGG subclass deficiency or IGA deficiency). Symptomatic coronary artery disease. Patient undergoing chemotherapy treatment. Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study. Evidence of active infection.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Efficacy Unilateral Control<br>Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm) | Device: non-coated Intranasal Splint<br>* placement of non-coated intranasal splint following FESS<br>|
| Experimental: Efficacy Unilateral Treatment<br>Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm) | Device: Sinexus Intranasal Splint<br>* placement of Sinexus Intranasal Splint placed following FESS<br>|
| Experimental: Safety/PK Bilateral Treatment<br>Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS | Device: Sinexus Intranasal Splint<br>* placement of Sinexus Intranasal Splint placed following FESS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success Rate | Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side. | Baseline | 
| Reduction in Ethmoid Sinus Inflammation | Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle Turbinate Lateralization | Position of the middle turbinate was assessed using a 4-point categorical scale (medialized, normal, partially lateralized, lateralized). For Lateralized Middle Turbinate, a sinus is counted once if this occurs at least once during the 30 Day timeframe. Lateralized Middle Turbinate (worse outcome), if left unaddressed, is often the cause of sinus obstruction. | 30 days | 
| Middle Meatus Patency | Patency of the middle meatus was assessed using a 3-point categorical scale (patent, narrowed, obstructed). Analysis included patent (better outcome) vs narrowed/obstructed (worse outcome). | 30 days | 
| Significant Adhesion Occurrence | Adhesion formation was assessed using a 5-point categorical scale (none, small/non-obstructing, obstructing/easily separated, *dense/obstructing/difficult to separate, *severe/complete adhesion to lateral nasal wall) with significant adhesion denoted by * | 30 days | 
| Polypoid Tissue Changes | Polyp formation in the ethmoid sinus assessed using an accepted 5-point categorical scale: 0-no visible nasal polyp (NP), 1-small amount NP confined in the middle meatus (MM); 2-multiple NP confined in MM; 3-NP extending beyond MM, within the sphenoethmoid recess not totally obstructing, or both; 4-NP completely obstructing the nasal cavity. 0 is best, and 4 is worst. When a patient's sinus has a change in polyp score at Day 30 it is counted as one. | 30 days |