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
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 April 14, 2014