Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-31 @ 8:59 PM
Study NCT ID:
NCT01894503
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2013-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Sponsor:
Intersect ENT
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S8PK
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 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: