Healthcare Utilization and Outcomes of FinESS Treatment in the Office (RELIEF)

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

Study Overview

• Status: Completed
• Conditions: Rhinosinusitis
• Intervention / Treatment: Device: FinESS Sinus Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Central California ENT
  • Colorado
    • Denver, Colorado, United States, 80120
      • South Denver ENT and Allergy
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • ENT and Allergy Associates
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT and Allergy
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Ear, Nose and Throat
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Coastal Ear, Nose and Throat Associates
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Midwest Ear, Nose and Throat
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Ear, Nose and Throat
    • Boerne, Texas, United States, 78006
      • Texas Sinus Center
    • Dallas, Texas, United States, 75205
      • The Snoring Center
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Advanced Otolaryngology PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon Dilation; Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.	Device: FinESS Sinus Treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Entellus Medical, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: September 29, 2009
• First Posted (Estimate): September 30, 2009

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Rhinosinusitis; Endoscopic sinus surgery; Respiratory tract diseases; Otorhinolaryngologic diseases; Respiratory tract infections; Balloon catheters; Office treatment; FinESS Sinus Treatment
• Other Study ID Numbers: 1630-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes