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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01894503
First received: July 3, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 sinus implant
Phase 3

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: Drug Eluting Sinus Implant
S8 sinus implant
Drug: S8 sinus implant

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01894503

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

No publications provided

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01894503     History of Changes
Other Study ID Numbers: P500-0513
Study First Received: July 3, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014