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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Central California ENT
Fresno, California, United States
South Denver ENT and Allergy
Denver, Colorado, United States
ENT and Allergy Associates
Trumbull, Connecticut, United States
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.
Time frame: Baseline and 12 months post procedure
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.
Time frame: 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.
Time frame: Baseline and 12 months post procedure
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NorthShore University
Evanston, Illinois, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
St. Cloud Ear, Nose and Throat
Saint Cloud, Minnesota, United States
Coastal Ear, Nose and Throat Associates
New Bern, North Carolina, United States
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, United States
Holston Medical Center
Kingsport, Tennessee, United States
Austin Ear, Nose and Throat
Austin, Texas, United States
...and 3 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months post procedure