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A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Dilation | Experimental | Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FinESS Sinus Treatment | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Sino-Nasal Outcomes Test | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score. | Baseline and 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California ENT | Fresno | California | 93720 | United States | ||
| South Denver ENT and Allergy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24358625 | Result | Levine SB, Truitt T, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):665-71. doi: 10.1177/000348941312201101. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Dilation | Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and 12 months post procedure |
| Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | Baseline and 12 months post procedure |
| Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | Baseline and 12 months post procedure |
| Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | Baseline and 12 months post procedure |
| Number of Participants Using Nasal Steroids | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | Baseline and 12 months post procedure |
| Number of Participants Using Antihistamines | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | Baseline and 12 months post procedure |
| Number of Participants Using Antibiotics | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | Baseline and 12 months post procedure |
| Number of Participants With Device and/or Procedure-related Adverse Events | Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure. | Baseline through 12 months post procedure |
| Denver |
| Colorado |
| 80120 |
| United States |
| ENT and Allergy Associates | Trumbull | Connecticut | 06611 | United States |
| NorthShore University | Evanston | Illinois | 60201 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| St. Cloud Ear, Nose and Throat | Saint Cloud | Minnesota | 56303 | United States |
| Coastal Ear, Nose and Throat Associates | New Bern | North Carolina | 28562 | United States |
| Midwest Ear, Nose and Throat | Sioux Falls | South Dakota | 57108 | United States |
| Holston Medical Center | Kingsport | Tennessee | 37660 | United States |
| Austin Ear, Nose and Throat | Austin | Texas | 78705 | United States |
| Texas Sinus Center | Boerne | Texas | 78006 | United States |
| The Snoring Center | Dallas | Texas | 75205 | United States |
| Advanced Otolaryngology PC | Richmond | Virginia | 23235 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants treated with the FinESS Sinus Treatment device.
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Dilation | Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. |
| 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 | Count of Participants | Participants |
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| Previous sinus surgery | Count of Participants | Participants |
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| Affected sinuses | Count of Participants | 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 | Sino-Nasal Outcomes Test | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score. | All treated participants with baseline and 12-month SNOT-20 scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
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| Secondary | Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | All treated participants with baseline and 12-month RSI scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
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| Secondary | Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | All treated participants with baseline and 12-month RSI scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
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| Secondary | Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | All treated participants with baseline and 12-month RSI scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
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| Secondary | Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 1 of the questionnaire scores symptoms related to chronic rhinosinusitis on a 6-point scale with "0" indicating no symptoms and "5" indicating very severe symptoms. There are 4 symptoms domains: nasal, facial, oropharyngeal, and systemic. RSI domain scores are calculated by summing the score of the specific domain question, dividing by the number of domain questions, and multiplying by 20 to obtain a standardized score. Scores can range from 0 to 100 with higher scores indicating worse symptoms. | All treated participants with baseline and 12-month RSI scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post procedure |
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| Secondary | Number of Participants Using Nasal Steroids | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | All treated participants with baseline and 12-month RSI scores. | Posted | Count of Participants | Participants | Baseline and 12 months post procedure |
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| Secondary | Number of Participants Using Antihistamines | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | All treated participants with baseline and 12-month RSI scores. | Posted | Count of Participants | Participants | Baseline and 12 months post procedure |
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| Secondary | Number of Participants Using Antibiotics | The Rhinosinusitis Symptom Inventory (RSI) is a self-administered quality of life questionnaire. Section 2 of the questionnaire records medication usage (nasal steroid sprays, anti-histamines, and antibiotics) over the past 12 months. | All treated participants with baseline and 12-month RSI scores. Four participants with blank responses at either interval are considered not evaluable. | Posted | Mean | Standard Deviation | number of antibiotic courses | Baseline and 12 months post procedure |
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| Secondary | Number of Participants With Device and/or Procedure-related Adverse Events | Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure. | All enrolled participants. Participants with unsuccessful procedures (sinus could not be accessed and dilated) were followed for 1 week post procedure. Treated participant are evaluated through 12 months post procedure. | Posted | Count of Participants | Participants | Baseline through 12 months post procedure |
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12 months post procedure for treated participants. Participants with unsuccessful treatment were followed for 1 week post procedure.
Adverse event information was collected on a standardized case report form at each follow-up visit.
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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 Dilation | Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. | 1 | 74 | 0 | 74 | 9 | 74 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness | Injury, poisoning and procedural complications | Systematic Assessment | Mild numbness in the treatment area (face, cheek, lip, teeth, eye) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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