Safety and Performance of the Steroid-Releasing S8 Sinus Implant
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/20/2018 |
| Start Date: | June 2013 |
| End Date: | October 2013 |
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
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.
S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus
obstruction.
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.
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.
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
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