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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01894503
First received: July 3, 2013
Last updated: March 13, 2017
Last verified: March 2017
  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 (mometasone furoate, 1350 mcg) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Masking: No masking
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 ]

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 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses
Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Other Name: Mometasone furoate sinus implant, 1350 mcg

Detailed Description:
The S8 PK study is an open label trial conducted at one clinical center in 5 adults with chronic sinusitis, who had prior endoscopic sinus surgery but experience 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 by measuring plasma mometasone furoate and cortisol concentrations through 30 days post-procedure.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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: March 13, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 23, 2017