Healthcare Utilization and Outcomes of FinESS Treatment in the Office
RELIEF
1 other identifier
interventional
74
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
October 27, 2020
CompletedOctober 27, 2020
October 1, 2020
3 years
September 29, 2009
September 15, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain
Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain
Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain
Baseline and 12 months post procedure
Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain
Baseline and 12 months post procedure
Number of Participants Using Nasal Steroids
Baseline and 12 months post procedure
- +3 more secondary outcomes
Study Arms (1)
Balloon Dilation
EXPERIMENTALBalloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hemophilia
- Cystic fibrosis
- Ciliary dysfunction
- Severe septal deviation causing obstruction of the ostiomeatal unit
- Pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Central California ENT
Fresno, California, 93720, United States
South Denver ENT and Allergy
Denver, Colorado, 80120, United States
ENT and Allergy Associates
Trumbull, Connecticut, 06611, United States
NorthShore University
Evanston, Illinois, 60201, United States
Advanced ENT and Allergy
Louisville, Kentucky, 40207, United States
St. Cloud Ear, Nose and Throat
Saint Cloud, Minnesota, 56303, United States
Coastal Ear, Nose and Throat Associates
New Bern, North Carolina, 28562, United States
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, 57108, United States
Holston Medical Center
Kingsport, Tennessee, 37660, United States
Austin Ear, Nose and Throat
Austin, Texas, 78705, United States
Texas Sinus Center
Boerne, Texas, 78006, United States
The Snoring Center
Dallas, Texas, 75205, United States
Advanced Otolaryngology PC
Richmond, Virginia, 23235, United States
Related 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. Ann Otol Rhinol Laryngol. 2013 Nov;122(11):665-71. doi: 10.1177/000348941312201101.
PMID: 24358625RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Clinical Research & Publications Manager
- Organization
- Stryker ENT
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
October 27, 2020
Results First Posted
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share