Safety and Performance of the Steroid-Releasing S8 Sinus Implant

Chronic Sinusitis Clinical Trial

— S8PK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894503
• Other study ID #: P500-0513
• Status: Completed
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• S8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Locations

Country	Name	City	State
United States	Sacramento ENT	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Sinuses With Successful Implant Delivery	Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure	End of baseline procedure
Secondary	Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ	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.	Days 3, 7, 14, 21 and 30