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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg) Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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
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
Study Start Date : June 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 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: SINUVA (mometasone furoate) sinus implant




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01894503     History of Changes
Other Study ID Numbers: P500-0513
First Posted: July 10, 2013    Key Record Dates
Results First Posted: June 25, 2018
Last Update Posted: July 18, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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