Healthcare Utilization and Outcomes of FinESS Treatment in the Office
NCT ID: NCT00986830
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2009-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Balloon Dilation
Balloon dilation of the maxillary sinuses using the FinESS Sinus Treatment device.
FinESS Sinus Treatment
Interventions
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FinESS Sinus Treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* Cystic fibrosis
* Ciliary dysfunction
* Severe septal deviation causing obstruction of the ostiomeatal unit
* Pregnant females
18 Years
ALL
No
Sponsors
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Entellus Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Central California ENT
Fresno, California, United States
South Denver ENT and Allergy
Denver, Colorado, United States
ENT and Allergy Associates
Trumbull, Connecticut, United States
NorthShore University
Evanston, Illinois, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
St. Cloud Ear, Nose and Throat
Saint Cloud, Minnesota, United States
Coastal Ear, Nose and Throat Associates
New Bern, North Carolina, United States
Midwest Ear, Nose and Throat
Sioux Falls, South Dakota, United States
Holston Medical Center
Kingsport, Tennessee, 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
Advanced Otolaryngology PC
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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1630-001
Identifier Type: -
Identifier Source: org_study_id