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Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Sinus Dilation | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XprESS device and PathAssist confirmation tools | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success: Sinuses Successfully Treated With Balloon Dilation | Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus. | Index procedure |
| Complications | Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events. | Index procedure through 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life From Baseline Through Completion | Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score. |
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Inclusion Criteria:
Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.
Exclusion Criteria:
History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Valley ENT | Phoenix | Arizona | 85032 | United States | ||
| Willamette ENT and Facial Plastic Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27888649 | Result | Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):221-229. doi: 10.1002/alr.21889. Epub 2016 Nov 26. |
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Sequential enrollment of eligible participants at sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Balloon Sinus Dilation using XprESS and PathAssist Devices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Balloon Sinus Dilation using XprESS and PathAssist Devices. |
| 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 | Technical Success: Sinuses Successfully Treated With Balloon Dilation | Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus. | All sinus dilations attempted in all participants | Posted | Number | sinus dilation attempts | Index procedure | Sinuses | Sinuses |
|
|
6 months
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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 | Balloon Sinus Dilation | Balloon Sinus Dilation using XprESS and PathAssist Devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen O'Malley | Entellus Medical | 763-463-1598 | 952 | eomalley@entellusmedical.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D000096825 | Rhinosinusitis |
| D065631 | Rhinitis, Allergic |
| D010254 | Paranasal Sinus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Baseline to 6-month follow-up |
| Number of Subjects Who Undergo a Revision or Additional Surgery During the Study | Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported | Procedure-6 month follow up |
| Salem |
| Oregon |
| 97302 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Alamo ENT and Associates | San Antonio | Texas | 78258 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Sinuses |
|
|
| Primary | Complications | Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events. | All participants | Posted | Number | participants | Index procedure through 3-month follow-up |
|
|
|
| Secondary | Change in Quality of Life From Baseline Through Completion | Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score. | All participants | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6-month follow-up |
|
|
|
|
| Secondary | Number of Subjects Who Undergo a Revision or Additional Surgery During the Study | Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported | All participants | Posted | Count of Participants | Participants | Procedure-6 month follow up |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D012220 | Rhinitis |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |