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

医学 射频消融术 临床终点 生活质量(医疗保健) 鼻子 可视模拟标度 不利影响 烧蚀 内科学 外科 鼻息肉 临床试验 护理部
作者
Greg E. Davis,Randall A. Ow,David M. Yen,Ellen M. O’Malley,Anthony G. Del Signore
出处
期刊:Ear, nose, & throat journal [SAGE]
标识
DOI:10.1177/01455613241285134
摘要

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.
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