The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dilation of frontal recess and/or sphenoid sinus ostia
Upland ENT
Upland, California, United States
Colorado ENT
Denver, Colorado, United States
St. Elizabeth Medical Center
Brighton, Massachusetts, United States
Patency of treated target site
Patency assessed by investigator via endoscopic evaluation of the target site
Time frame: Patency immediately post device expansion and removal
Patency of treated target site
Patency assessed by investigator via endoscopic evaluation of the target site
Time frame: 1 month and 3 months
Reports of sinus related adverse events during the 3 months follow-up period
Time frame: up to 3 months
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