Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis

Abstract

Objective: Chronic rhinitis substantially impacts a person's quality of life. We evaluated a novel, multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Methods: This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). The primary safety endpoint was the incidence of related serious adverse events. Results: Seventy-nine of 80 enrolled participants completed 6-month follow-up. Statistically significant improvements were observed for mean change in rTNSS (-4.2), ETDQ-7 (-1.2), NOSE (-33.5), and mini-RQLQ (-1.8; P < .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments (P < .0001) with no significant differences between subgroups. Higher baseline rTNSS was associated with greater improvements at follow-up. One serious adverse event of epistaxis was reported. Conclusions: The results of this study demonstrate the efficacy and safety of a multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Significant improvements were observed in rTNSS, ETDQ-7, NOSE, and mini-RQLQ assessments.Study registration: www.clinicaltrials.gov. Unique identifier NCT05591989.

Keywords: ETDQ-7; Eustachian tube dysfunction; NOSE; chronic rhinitis; impedance-controlled radiofrequency ablation; mini-RQLQ; posterior nasal nerve ablation; postnasal drip/drainage; quality of life; rTNSS.