Prospective, Randomized Trial of Efficacy of the Hydrodebrider during Functional Endoscopic Sinus Surgery
This study will a randomized, single-blind controlled clinical trial that will compare the efficacy of the HydrodebriderTM to conventional endoscopic sinus instrumentation for removal of eosinophilic mucin and/or fungal debris in maxillary sinus surgery. A total of 32 maxillary sinuses in up to 27 subjects will be randomized in the study. The study setting will be the University of Texas Southwestern Medical Center affiliated academic faculty practice. All subjects will be recruited from the practices of Pete Batra, MD, Brad Marple, MD, and Matt Ryan, MD from the Department of Otolaryngology – Head and Neck Surgery. The anticipated study duration is 6 months.
Patient is >18 years old.
Patient has clinical diagnosis of allergic fungal rhinosinusitis or maxillary fungal ball.
Patient requires unilateral or bilateral FESS (defined as a minimum of maxillary antrostomy).