Chronic Rhinosinusitis Clinical Trial
— OASISOfficial title:
OASIS Global Sinus Surgery Registry
NCT number | NCT02347943 |
Other study ID # | CPR005044 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2015 |
Est. completion date | November 1, 2015 |
Verified date | February 2019 |
Source | Acclarent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Terminated |
Enrollment | 252 |
Est. completion date | November 1, 2015 |
Est. primary completion date | November 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Acclarent |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Completing Follow-Up Visits | 2 years |
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