Chronic Sinusitis
Conditions
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.
Interventions
DRUGS8 Sinus Implant (mometasone furoate, 1350 mcg)
Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Sponsors
Intersect ENT
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sinuses With Successful Implant Delivery | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Demographic and Baseline Clinical Characteristics In-office bilateral placement of two S8 Sinus Implants | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Demographic and Baseline Clinical Characteristics |
|---|---|
| Age, Continuous | 46.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
Time frame: End of baseline procedure
Population: Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| S8 Sinus Implant | Number of Sinuses With Successful Implant Delivery | 10 Sinuses |
Secondary
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.
Time frame: Days 3, 7, 14, 21 and 30
Population: Per-treatment evaluable population consisting of all patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Baseline | 0 participants |
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Day 3 | 3 participants |
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Day 7 | 1 participants |
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Day 14 | 2 participants |
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Day 21 | 0 participants |
| S8 Sinus Implant | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ | Day 30 | 0 participants |