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This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinexus Intranasal Splint | Experimental | Patient receives a drug-coated intranasal splint |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid-Eluting Sinexus Intranasal Splint | Device | Intranasal drug-coated splint placed after functional endoscopic surgery (FESS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) | 30 days | |
| Device Placement Success Rate | A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses. | At the time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities | Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified. | Baseline and 30 days |
| Number of Sinuses With Significant Post-operative Adhesion Formation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Ear, Nose Thraot | Fresno | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sinexus Intranasal Splint | Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall. |
| 30 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sinexus Intranasal Splint | Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS) |
| 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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| Region of Enrollment | Number | participants |
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| Lund MacKay CT Stage | The Lund Mackay CT Staging system is a scale ranging from 0 to 24, where lower scores represent a better condition. each sinus is scored 0, 1 or 2, where 0=no opacification, 1=partial opacification and 2=complete opacification. 12 areas of the anatomy are evaluated, resulting in the scale ranging from 0 to 24. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Proportion of Patients with Polyps | Number | participants |
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| Proportion of Patients Undergoing Revision Surgery | Number | participants |
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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 | Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) | Posted | Number | 95% Confidence Interval | Number of Sinuses | 30 days | number of sinuses | Participants |
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| Primary | Device Placement Success Rate | A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses. | Posted | Number | Sinuses | At the time of procedure | Sinuses Attempted | Participants |
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| Secondary | Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities | Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified. | Posted | Number | Pts. w/ significant IOP elevation | Baseline and 30 days |
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| Secondary | Number of Sinuses With Significant Post-operative Adhesion Formation | Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall. | Posted | Number | sinuses | 30 days | Sinuses | Participants |
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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 | Sinexus Intranasal Splint | Patient receives a drug-coated intranasal splint Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS) | 3 | 50 | 23 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders |
| |||
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Stambaugh | Intersect ENT | 650-641-2103 | jstambaugh@intersectent.com |
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| Sinuses |
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