Temperature‐controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open‐label, single arm multicenter study
Jordan Pritikin, Stacey L. Silvers, Jeffrey Rosenbloom, Bryan Davis, Anthony Del Signore, Ahmad R. Sedaghat, Bobby A. Tajudeen, Isaac L. Schmale, Jack Lyons, Jacquelynne P. Corey, Rakesh K. Chandra
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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 < 0.0001); the responder rate was 95.7% (95% CI: 0.88 to 0.99; p < 0.0001). CT evaluation at 3 months showed statistically significant reductions in the SSB with the greatest reduction in the middle thickness (mean change -3.4 [SD 1.8] mL, 95% CI: -4.0 to -2.8; p < 0.0001). Minimal adverse events with any relationship to the device or procedure were reported; none were serious in nature and no septal perforations occurred. CONCLUSIONS: This study demonstrates that TCRF treatment of SSB hypertrophy is well tolerated and effective at reducing both SSB size and symptoms of NAO at 3 months posttreatment.