Global Sinus Surgery Registry (OASIS)

Integra LifeSciences

Status: Terminated

Conditions: Chronic Rhinosinusitis; Recurrent Acute Rhinosinusitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02347943

CPR005044

Details and patient eligibility

About

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).

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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