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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Sinusitis
Intervention Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Enrollment 5
Recruitment Details A prospective, single-center open label study treating adult patients with recurrent polyposis after bilateral total ethmoidectomy. Study period 9 July 2013 to 17 July 2013
Pre-assignment Details A total of six patients were enrolled (consented). One patient did not have the required grade 2 polyposis on at least one ethmoid side and was excluded. The remaining five patients meet all eligibility criteria and underwent an in-office bilateral placement of two S8 Sinus Implants. All five patients completed follow-up through the Day 90 visit.
Arm/Group Title S8 Sinus Implant
Hide Arm/Group Description Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Demographic and Baseline Clinical Characteristics
Hide Arm/Group Description In-office bilateral placement of two S8 Sinus Implants
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
46.2
(37 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
1
  20.0%
Not Hispanic or Latino
4
  80.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Sinuses With Successful Implant Delivery
Hide Description Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure
Time Frame End of baseline procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.
Arm/Group Title S8 Sinus Implant
Hide Arm/Group Description:
Implant delivery success
Overall Number of Participants Analyzed 5
Overall Number of Units Analyzed
Type of Units Analyzed: Sinuses
10
Count of Units
Unit of Measure: Sinuses
10
 100.0%
2.Secondary Outcome
Title Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
Hide Description 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.
Time Frame Days 3, 7, 14, 21 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Per-treatment evaluable population consisting of all patients
Arm/Group Title S8 Sinus Implant
Hide Arm/Group Description:
In-office bilateral placement of the S8 Sinus Implant (1350 mcg of mometasone furoate) in the ethmoid sinuses
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Baseline 0
Day 3 3
Day 7 1
Day 14 2
Day 21 0
Day 30 0
Time Frame Adverse Events and Serious Adverse Events were recorded and tabulated through Day 90.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title S8 Sinus Implant
Hide Arm/Group Description Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate sinus implant, 1350 mcg) in the ethmoid sinuses S8 Sinus Implant (mometasone furoate, 1350 mcg): Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
All-Cause Mortality
S8 Sinus Implant
Affected / at Risk (%)
Total   0/5 (0.00%)    
Hide Serious Adverse Events
S8 Sinus Implant
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
S8 Sinus Implant
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
Infections and infestations   
Acute sinusitis  1 [1]  1/5 (20.00%)  1
Nervous system disorders   
Headache  1 [2]  1/5 (20.00%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
Mild, maxillary sinus
[2]
Mild
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Stambaugh, Vice President of Clinical & Medical Affairs
Organization: Intersect ENT, Inc.
Phone: 650-641-2103
EMail: jstambaugh@intersectent.com
Layout table for additonal information
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01894503    
Other Study ID Numbers: P500-0513
First Submitted: July 3, 2013
First Posted: July 10, 2013
Results First Submitted: April 10, 2018
Results First Posted: June 25, 2018
Last Update Posted: July 18, 2018