Safety and Performance of the Steroid-Releasing S8 Sinus Implant

Phase 2

Completed

• Conditions: Chronic Sinusitis
• Interventions: Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)

• Registration Number: NCT01894503
• Lead Sponsor: Intersect ENT

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Disposition First Submitted: 2015-03-19
• Disposition First Submitted QC: 2015-03-19
• Disposition First Posted: 2015-04-08
• Status Verified: 2017-03
• Results First Submitted: 2018-04-10
• Results First Submitted QC: 2018-05-23
• Last Update Submitted: 2018-06-22
• Results First Posted: 2018-06-25
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S8 Sinus Implant	S8 Sinus Implant (mometasone furoate, 1350 mcg)	Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Primary Outcome Measures

Name	Time	Method
Number of Sinuses With Successful Implant Delivery	End of baseline procedure	Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ	Days 3, 7, 14, 21 and 30	Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.

Trial Locations

Locations (1)

Sacramento ENT; 🇺🇸 Sacramento, California, United States