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
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Los Angeles, CA
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Albuquerque, NM
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Alexandria, LA
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Atlanta, GA
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Berwyn, IL
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Bethesda, MD
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Chicago, IL
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from
Evans, GA
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mi
from
Fort Wayne, IN
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from
Fort Worth, TX
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from
Helena, MT
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from
Henderson, NV
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Houston, TX
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from
Knoxville, TN
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Long Beach, NY
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from
McKinney, TX
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mi
from
Miami, FL
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from
Nashville, TN
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from
New York, NY
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from
Phoenix, AZ
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from
Sacramento, CA
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from
Saint Peters, MO
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from
San Antonio, TX
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from
San Francisco, CA
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mi
from
West Burlington, IA
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