search
Back to results

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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
S8 Sinus Implant (mometasone furoate, 1350 mcg)
Sponsored by
Intersect ENT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sacramento ENT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S8 Sinus Implant

Arm Description

Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Outcomes

Primary Outcome Measures

Number of Sinuses With Successful Implant Delivery
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

Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
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.

Full Information

First Posted
July 3, 2013
Last Updated
June 22, 2018
Sponsor
Intersect ENT
search

1. Study Identification

Unique Protocol Identification Number
NCT01894503
Brief Title
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Acronym
S8PK
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S8 Sinus Implant
Arm Type
Experimental
Arm Description
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Intervention Type
Drug
Intervention Name(s)
S8 Sinus Implant (mometasone furoate, 1350 mcg)
Other Intervention Name(s)
SINUVA (mometasone furoate) sinus implant
Intervention Description
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Primary Outcome Measure Information:
Title
Number of Sinuses With Successful Implant Delivery
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
Secondary Outcome Measure Information:
Title
Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Ow, MD
Organizational Affiliation
Sacramento ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento ENT
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan

Learn more about this trial

Safety and Performance of the Steroid-Releasing S8 Sinus Implant

We'll reach out to this number within 24 hrs