Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.

Publication/Presentation Date

4-1-2023

Abstract

OBJECTIVE: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis.

METHODS: A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated.

RESULTS: Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both

CONCLUSIONS: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post-procedure.

TRIAL REGISTRATION: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397.

LEVEL OF EVIDENCE: 4.

Volume

8

Issue

2

First Page

367

Last Page

372

ISSN

2378-8038

Disciplines

Medicine and Health Sciences

PubMedID

37090860

Department(s)

Department of Surgery

Document Type

Article

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