Status:
COMPLETED
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Lead Sponsor:
Intersect ENT
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 pr...
Eligibility Criteria
Inclusion
- Key
- 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
- Required use of mometasone furoate within 2 weeks prior to implant procedure
- Significant scarring or adhesions of the sinus
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01894503
Start Date
June 1 2013
End Date
October 1 2013
Last Update
July 18 2018
Active Locations (1)
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1
Sacramento ENT
Sacramento, California, United States, 95815