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

This study has been completed.
Information provided by (Responsible Party):
Intersect ENT Identifier:
First received: July 3, 2013
Last updated: July 15, 2015
Last verified: May 2015

The purpose of this study is to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post sinus surgery patients who present with recurrent sinus obstruction.

Condition Intervention Phase
Chronic Sinusitis
Drug: S8 mometasone furoate sinus implant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Successful deployment on implant into the ethmoid sinus [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: June 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S8 mometasone furoate sinus implant
S8 mometasone furoate eluting sinus implant
Drug: S8 mometasone furoate sinus implant


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of chronic sinusitis
  • Prior sinus surgery with ethmoidectomy
  • Recurrent sinus obstruction due to polyps

Exclusion Criteria:

  • Required use of mometasone furoate
  • Significant scarring of the sinus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01894503

United States, California
Sacramento ENT
Sacramento, California, United States, 95815
Sponsors and Collaborators
Intersect ENT
Principal Investigator: Randall Ow, MD Sacramento ENT
  More Information

No publications provided

Responsible Party: Intersect ENT Identifier: NCT01894503     History of Changes
Other Study ID Numbers: P500-0513
Study First Received: July 3, 2013
Last Updated: July 15, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 08, 2015