Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Rhinosinusitis Clinical Trial

— RELIEF  

Official title:

Healthcare Utilization and Outcomes of FinESS Treatment in the Office

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986830
• Other study ID #: 1630-001
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2020
• Source: Entellus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinosinusitis

Intervention

Device:
• FinESS Sinus Treatment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Entellus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. An — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline and 12 months post procedure
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.	Baseline through 12 months post procedure