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The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XprESS Multi-Sinus Dilation Tool | Experimental | Balloon sinus dilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XprESS Multi-Sinus Dilation Tool | Device | Sinus balloon dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SNOT-20 Score | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. | Baseline and 1-year post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Revision Sinus Surgery | The number of participants who require revision sinus surgery to address continuing sinus symptoms. | 1-year post procedure |
| Number of Participants With Serious Device and/or Procedure-related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Entellus Medical | Plymouth | Minnesota | 55447 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24598043 | Result | Gould J, Alexander I, Tomkin E, Brodner D. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):156-63. doi: 10.2500/ajra.2014.28.4043. Epub 2014 Feb 14. |
| Label | URL |
|---|---|
| Entellus Medical patient-facing website about sinusitis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Sinus Dilation | Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who underwent an attempted sinus dilation procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Sinus Dilation | Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool |
| 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 | Change in SNOT-20 Score | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. | All participants who had 1 or more sinuses successfully treated with the XprESS device and both baseline and 1-year follow-up SNOT-20 scores available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1-year post procedure |
|
Adverse events were systematically collected by standardized case report forms through 1 year post procedure.
All SAEs, regardless of relationship to the study device and/or procedure, were reported. The protocol only required nonserious AEs that were classified by the Investigator as device-related and/or procedure-related to be collected.
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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 the XprESS Multi-Sinus Dilation Tool |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tick-borne illness | Infections and infestations | Systematic Assessment | Tick-borne illness treated with intravenous antibiotics. Not related to the study device or procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure.
| Through 1-year post procedure follow-up |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of sinusitis | Count of Participants | Participants |
|
| Baseline SNOT-20 score | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Revision Sinus Surgery | The number of participants who require revision sinus surgery to address continuing sinus symptoms. | All participants with 1 or more sinuses successfully treated with the XprESS device. | Posted | Count of Participants | Participants | 1-year post procedure |
|
|
|
| Secondary | Number of Participants With Serious Device and/or Procedure-related Adverse Events | Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure. | All enrolled participants. | Posted | Count of Participants | Participants | Through 1-year post procedure follow-up |
|
|
|
| 0 |
| 82 |
| 1 |
| 82 |
| 0 |
| 82 |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |