Safety and Performance of the Steroid-Releasing S8 Sinus Implant (S8PK)

Intersect ENT

Status and phase: Completed; Phase 2

Conditions: Chronic Sinusitis

Treatments: Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01894503

P500-0513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

S8 Sinus Implant

Experimental group

Description:

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

Treatment:

Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)