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The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
The ENCORE Study is a prospective open-label, non-randomized, multicenter study in CS patients who had undergone prior endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy and present with bilateral ethmoid polyposis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S8 Sinus Implant | Experimental | corticosteroid-eluting sinus implant containing 1350 mcg of mometasone furoate (MF) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S8 Sinus Implant | Combination Product | In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Implant-Related Serious Adverse Events | Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365. | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT-22 Total Score | Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value from baseline. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Manes, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento ENT | Sacramento | California | 95815 | United States | ||
| Yale University School of Medicine |
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Patients were recruited at 10 sites across the US between November 2017 and January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | S8 Sinus Implant | Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (200 mcg) once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2017 | Sep 24, 2019 |
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| Baseline, 90 days, 180 days |
| Nasal Obstruction/Congestion Score | Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value at baseline. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion. | Baseline, 90 days, 180 days |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| DuPage Medical Group | Naperville | Illinois | 60540 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | United States |
| Associated Surgical Specialists | Covington | Louisiana | 70433 | United States |
| BreatheAmerica of Albuquerque | Albuquerque | New Mexico | 87109 | United States |
| Madison ENT | New York | New York | 10016 | United States |
| Charlotte Eye, Ear, Nose and Throat Associates | Concord | North Carolina | 29025 | United States |
| Bridgerland Clinical Research | North Logan | Utah | 84341 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | S8 Sinus Implant | Corticosteroid-eluting Sinus Implant with 1350 mcg of MF Mometasone furoate nasal spray (200 mcg) once daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| SNOT-22 | Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms. | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| Nasal Obstruction/Congestion ≥ 2 | Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Ethmoid Sinus Obstruction | Estimated visually based on endoscopic examination on a scale of 0% (no obstruction) to 100% (complete obstruction of the ethmoid cavity by polyps, edema, and/or scarring). | Mean | Standard Deviation | percent of obstruction |
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| 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 Participants With Implant-Related Serious Adverse Events | Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365. | Posted | Count of Participants | Participants | 365 days |
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| Secondary | SNOT-22 Total Score | Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value from baseline. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms. | Analysis population includes subjects with available data at that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 90 days, 180 days |
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| Secondary | Nasal Obstruction/Congestion Score | Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value at baseline. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion. | Analysis population includes subjects with available data at that time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 90 days, 180 days |
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Adverse events were collected from enrollment through Day 365.
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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 | Corticosteroid-eluting Sinus Implant with1350 mcg MF. MFNS (200 mcg) once daily | 0 | 50 | 4 | 50 | 11 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| brain hypoxia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| small intestine obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment | implant-related adverse event |
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| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | implant-related adverse event |
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| nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | implant-related adverse event |
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| rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | implant-related adverse event |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2018 | Sep 24, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
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