Clinical trial NCT02347943: Global Sinus Surgery Registry
Official title: OASIS Global Sinus Surgery Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Rhinosinusitis
Recurrent Acute Rhinosinusitis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2015-01-28
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed by an ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) undergoing a primary transnasal endoscopic sinus surgery.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Completing Follow-Up Visits
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Evans
country: United States
state: Georgia
city: Berwyn
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: West Burlington
country: United States
state: Iowa
city: Alexandria
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Saint Peters
country: United States
state: Missouri
city: Helena
country: United States
state: Montana
city: Henderson
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Long Beach
country: United States
state: New York
city: New York
country: United States
state: New York
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References: