The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis.
The purpose of the research is to examine the effectiveness of navigation in maxillary sinus balloon dilation for the treatment of chronic maxillary rhinosinusitis. Adult patients (18 and over) with a confirmed diagnosis of chronic maxillary rhinosinusitis without nasal polyposis (CRSwNP) will undergo maxillary balloon sinusotomy. Block randomization will be performed to determine which side will receive balloon sinusotomy with navigation and which will have balloon sinusotomy using traditional anatomic landmarks. Participants will be followed for approximately 1 month post-procedure for a total study participation time of approximately 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
50
The non-navigated device being used is the RELIEVA SPINPLUS® Balloon Sinusplasty System and the navigated device being used is the RELIEVA SPINPLUS® NAV Balloon Sinusplasty System. Both devices being used are standard devices that are currently FDA approved and used in practice for sinus dilation at Cedars-Sinai Medical Center.
Cedars Sinai
Los Angeles, California, United States
RECRUITINGSuccess Rate
There is a 30% expected improvement of success, in favor of navigation over non-navigation balloon sinuplasty devices.
Time frame: 12 months
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