Nonrandomized Prospective Study of an Upper Esophageal Sphincter (UES) Assist Device for Treating Laryngopharyngeal Reflux

Objectives:(1) Describe treatment of the heterogeneous disorder of laryngopharyngeal reflux (LPR) with a new upper esophageal sphincter (UES) assist medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. (2) Analyze the reduction of symptoms pre-therapy compared to posttherapy.Methods:Patients presenting with a reflux symptoms index (RSI) >13 and diagnosed with chronic cough, postnasal drip, globus, or throat clearing were included in the study. The UES assist device was fitted individually to apply external pressure above 20 mm Hg at the cricoid and worn when sleeping. The primary effectiveness endpoint was reduction of the RSI at 4 weeks. SF-36 Health Survey, Functional Outcomes of Sleep Questionnaire (FOSQ), and patient and physician satisfaction scores were secondary end points. Intent to treat (ITT) analysis was performed. Safety was based on reported adverse reactions.Results:Forty-four patients consented, with 42 (ITT) completing the study (age, 47 ± 13.1 years...