Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
252 participants
OBSERVATIONAL
2015-01-01
2015-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure
* Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines
* The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form
* Subject is able to read and understand local language
Exclusion Criteria
* Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III
* Planned external approaches (i.e. not trans-nasal)
* Planned off-label usage of balloon sinus dilation products.
* Balloon sinus dilation performed with a non-Acclarent balloon product
18 Years
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Evans, Georgia, United States
Berwyn, Illinois, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
West Burlington, Iowa, United States
Alexandria, Louisiana, United States
Bethesda, Maryland, United States
City of Saint Peters, Missouri, United States
Helena, Montana, United States
Henderson, Nevada, United States
Albuquerque, New Mexico, United States
Long Beach, New York, United States
New York, New York, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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CPR005044
Identifier Type: -
Identifier Source: org_study_id
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