Safety and Performance of the Steroid-Releasing S8 Sinus Implant

Study Overview
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Brief Summary
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The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.

Detailed Description
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The S8 PK study was a single-center, open label study treating 5 adult (18 years or older) patients diagnosed with chronic sinusitis, who had undergone prior bilateral total ethmoidectomy and later presented with recurrent nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. The S8 PK study assessed the safety, implant delivery to the ethmoid sinus, and systemic exposure to mometasone furoate (MF) by measuring plasma MF and cortisol concentrations through 30 days post-procedure.

Official Title
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A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 18 years of age or older Diagnosis of chronic sinusitis Prior bilateral total ethmoidectomy Recurrent sinus obstruction due to polyps grade 2 or higher Key Exclusion Criteria: Required use of mometasone furoate within 2 weeks prior to implant procedure Significant scarring or adhesions of the sinus

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
Intervention Model: Single Group Assignment
Interventional Model Description: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S8 Sinus Implant<br>Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses | Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)<br>* Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days<br>* Other names: SINUVA (mometasone furoate) sinus implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sinuses With Successful Implant Delivery | Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure | End of baseline procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml. | Days 3, 7, 14, 21 and 30 |