Phase 2
Completed N=5
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Chronic Sinusitis
Source: ClinicalTrials.gov NCT01894503 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Number of Sinuses With Successful Implant Delivery — 10 Sinuses
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Sinuses With Successful Implant Delivery |
10 | — |
| SECONDARY Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ |
0; 3; 1; 2; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01894503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.