The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Sinuplasty
Valley ENT
Tucson, Arizona, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
St. Elizabeth Medical Center
Boston, Massachusetts, United States
St. Paul's Hospital, ENT Department
Vancouver, British Columbia, Canada
Patency of Treated Area
Time frame: Immediately post procedure
Patency of Treated Area
Maxillary Sinus Ostia Patency of 33 patients analyzed.
Time frame: 3 months
Number of Participants With Device-related Adverse Events as a Measure of Safety
Time frame: 3 months
Patency of Treated Area
Maxillary Sinus Ostia Patency of 29 patients analyzed.
Time frame: 6 months
Patency of Treated Area
Maxillary Sinus Ostia of 27 patients analyzed.
Time frame: 12 months
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Charing Cross Hospital
London, United Kingdom