Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Not Applicable

Completed

Conditions: Rhinosinusitis

Interventions: Device: FinESS Sinus Treatment

Registration Number: NCT00986830

Lead Sponsor: Entellus Medical, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon Dilation	FinESS Sinus Treatment	Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.

Primary Outcome Measures

Name	Time	Method
Sino-Nasal Outcomes Test	Baseline and 12 months post procedure	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.

Secondary Outcome Measures

Name	Time	Method
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain	Baseline and 12 months post procedure	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.
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain	Baseline and 12 months post procedure	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.
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain	Baseline and 12 months post procedure	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.
Number of Participants With Device and/or Procedure-related Adverse Events	Baseline through 12 months post procedure	Number of participants with 1 or more adverse events considered possibly or definitely related to the FinESS device and/or balloon dilation procedure.
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain	Baseline and 12 months post procedure	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.
Number of Participants Using Nasal Steroids	Baseline and 12 months post procedure	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.
Number of Participants Using Antihistamines	Baseline and 12 months post procedure	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.
Number of Participants Using Antibiotics	Baseline and 12 months post procedure	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.

Trial Locations

Locations (13): Midwest Ear, Nose and Throat
🇺🇸
Sioux Falls, South Dakota, United States
Central California ENT
🇺🇸
Fresno, California, United States
Holston Medical Center
🇺🇸
Kingsport, Tennessee, United States
The Snoring Center
🇺🇸
Dallas, Texas, United States
Texas Sinus Center
🇺🇸
Boerne, Texas, United States
ENT and Allergy Associates
🇺🇸
Trumbull, Connecticut, United States
St. Cloud Ear, Nose and Throat
🇺🇸
Saint Cloud, Minnesota, United States
NorthShore University
🇺🇸
Evanston, Illinois, United States
Coastal Ear, Nose and Throat Associates
🇺🇸
New Bern, North Carolina, United States
South Denver ENT and Allergy
🇺🇸
Denver, Colorado, United States
Advanced ENT and Allergy
🇺🇸
Louisville, Kentucky, United States
Austin Ear, Nose and Throat
🇺🇸
Austin, Texas, United States
Advanced Otolaryngology PC
🇺🇸
Richmond, Virginia, United States