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Completed

NCT Number: NCT01894503

Safety and Performance of the Steroid-Releasing S8 Sinus Implant

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.

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sacramento ENT

Sacramento, California, 95815, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S8 Sinus Implant (mometasone furoate, 1350 mcg)

Drug

Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days

Other names: SINUVA (mometasone furoate) sinus implant

Primary outcomes

  1. Number of Sinuses With Successful Implant Delivery

    Time frame: 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 outcomes

  1. Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Intersect ENT

Industry

Registry information

Official study 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

Acronym: S8PK

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2013
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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