Safety and Performance of the Steroid-Releasing S8 Sinus Implant

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intersect ENT
• Treatments: Mometasone Furoate

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