This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Single arm
Central California Ear, Nose and Throat Medical Group
Fresno, California, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Loyola University Medical Center
Incidences of Device-related or Procedure-related Complications
Time frame: Through 12 months post-procedure
Patency of the Treated Area as Verified by CT Scan
Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.
Time frame: Post-treatment at 3 months
Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement
Symptomatic change in SNOT 20 scores on a 5-point Likert scale where "0" = no problem to "5" = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful.
Time frame: Post-treatment through 12 months
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...and 3 more locations