Temperature-controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open-label, single arm multicenter study

Nasal airway obstruction (NAO) is a highly prevalent disorder. Septal swell body (SSB) hypertrophy is an often overlooked contributor to NAO. SSB treatment may relieve symptoms of NAO. The objective of this study was to assess the clinical use of a temperature-controlled radiofrequency (TCRF) device to treat SSBs to improve symptoms in adults with NAO. In this prospective, multicenter, open-label, single arm study, patients with severe or extreme NAO related to SSB hypertrophy received bilateral TCRF treatment in the SSB area. The primary endpoint was improvement in Nasal Obstruction Symptom Evaluation (NOSE) Scale scores from baseline to 3 months postprocedure. A subset of study patients underwent computed tomography (CT) imaging to evaluate posttreatment changes in SSB size. Mean NOSE Scale scores significantly improved from 73.5 (SD 14.2) at baseline to 27.9 (SD 17.2) at 3 months postprocedure, a reduction of -45.3 (SD 21.4, 95% confidence interval [CI]: -50.4 to -40.1; p