Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.

Official Title
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Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Conditions
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Rhinosinusitis

Intervention / Treatment
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* Device: FinESS Sinus Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Male or female subjects Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation) Willing to comply with protocol requirements Able to provide consent Exclusion Criteria: Hemophilia Cystic fibrosis Ciliary dysfunction Severe septal deviation causing obstruction of the ostiomeatal unit Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon Dilation<br>Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device. | Device: FinESS Sinus Treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinosinusitis, Balloon catheters, Office treatment, Otorhinolaryngologic diseases, Respiratory tract infections, Respiratory tract diseases, FinESS Sinus Treatment, Endoscopic sinus surgery