Global Sinus Surgery Registry



Status:Terminated
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:January 1, 2015
End Date:November 1, 2015

Use our guide to learn which trials are right for you!

OASIS Global Sinus Surgery Registry

This study evaluates long-term safety and effectiveness of primary sinus surgery in a
real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute
rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using
commercially available sinus instrumentation (e.g. sinus balloon catheters, powered
microdebriders, manual instruments).


Inclusion Criteria:

- Age ≥ 18 years or minimum adult age as required by local regulations

- 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:

- Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and
Turbinate Reduction surgeries are not exclusions

- 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
We found this trial at
25
sites
2292
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from 02139
Phoenix, AZ
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1965
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from 02139
Albuquerque, NM
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1400
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from 02139
Alexandria, LA
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934
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from 02139
Atlanta, GA
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854
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from 02139
Berwyn, IL
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391
mi
from 02139
Bethesda, MD
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846
mi
from 02139
Chicago, IL
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854
mi
from 02139
Evans, GA
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727
mi
from 02139
Fort Wayne, IN
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1574
mi
from 02139
Fort Worth, TX
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2015
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from 02139
Helena, MT
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2362
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from 02139
Henderson, NV
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1601
mi
from 02139
Houston, TX
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815
mi
from 02139
Knoxville, TN
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180
mi
from 02139
Long Beach, NY
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2588
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from 02139
Los Angeles, CA
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1522
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from 02139
McKinney, TX
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1256
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from 02139
Miami, FL
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939
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from 02139
Nashville, TN
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180
mi
from 02139
New York, NY
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2617
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from 02139
Sacramento, CA
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1051
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from 02139
Saint Peters, MO
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1769
mi
from 02139
San Antonio, TX
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2690
mi
from 02139
San Francisco, CA
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1039
mi
from 02139
West Burlington, IA
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