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 |
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).
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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