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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S8 Sinus Implant | Experimental | Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S8 Sinus Implant (mometasone furoate, 1350 mcg) | Drug | Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End of baseline procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 3, 7, 14, 21 and 30 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Ow, MD | Sacramento ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento ENT | Sacramento | California | 95815 | United States |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | S8 Sinus Implant | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Demographic and Baseline Clinical Characteristics | In-office bilateral placement of two S8 Sinus Implants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted. | Posted | Count of Units | Sinuses | End of baseline procedure | Sinuses | Sinuses |
|
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Adverse Events and Serious Adverse Events were recorded and tabulated through Day 90.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S8 Sinus Implant | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | Mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Stambaugh, Vice President of Clinical & Medical Affairs | Intersect ENT, Inc. | 650-641-2103 | jstambaugh@intersectent.com |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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. | Per-treatment evaluable population consisting of all patients | Posted | Number | participants | Days 3, 7, 14, 21 and 30 |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment | Mild, maxillary sinus |
|
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.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|
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| Day 14 |
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| Day 21 |
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| Day 30 |
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