Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01894503
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : June 25, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Results First Submitted Date  ICMJE April 10, 2018
Results First Posted Date  ICMJE June 25, 2018
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
Successful deployment on implant into the ethmoid sinus [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
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: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Sinusitis
Intervention  ICMJE Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Other Name: SINUVA (mometasone furoate) sinus implant
Study Arms  ICMJE Experimental: S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Intervention: Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01894503
Other Study ID Numbers  ICMJE P500-0513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan
Responsible Party Intersect ENT
Study Sponsor  ICMJE Intersect ENT
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Randall Ow, MD Sacramento ENT
PRS Account Intersect ENT
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP