Global Sinus Surgery Registry (NCT02347943) | Clinical Trial Compass
TerminatedNot Applicable
Global Sinus Surgery Registry
United States252 participantsStarted 2015-01-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants Completing Follow-Up Visits