NCT01894503

Safety and Performance of the Steroid-Releasing S8 Sinus Implant

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DRUG	S8 Sinus Implant (mometasone furoate, 1350 mcg)	Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-07-10
• Last updated: 2018-07-18
• Results posted: 2018-06-25

Locations

1 site across 1 country: United States