A Randomized Controlled Trial Comparing Posterior Nasal Nerve Ablation Procedures for Chronic Rhinitis

Официальное название

Radiofrequency Ablation (RhinAer, Neuromark) vs. Cryoablation (ClariFix) of the Posterior Nasal Nerve for Chronic Rhinitis: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn which procedural intervention most effectively reduces symptoms of chronic rhinitis (non-allergic rhinitis) in adult patients (18 years and older). The main questions it aims to answer are: * Which procedural intervention leads to the greatest reduction in total nasal symptom scores (TNSS)? * Which procedural intervention leads to the greatest improvement in sinonasal quality of life as measured by the SNOT-22? Researchers will compare radiofrequency ablation (RhinAer or Neuromark) and cryotherapy (ClariFix) to see if there are differences in symptom reduction and durability of response across treatments. Participants will: * Be randomly assigned to one of three FDA-cleared posterior nasal nerve ablation procedures (RhinAer, Neuromark, or ClariFix) * Complete validated symptom questionnaires (TNSS and SNOT-22) before and after their procedure * Have their relevant medical records reviewed (demographics, clinical history, prior rhinitis treatments)

Подробное описание

Chronic rhinitis (non-allergic/vasomotor rhinitis) affects an estimated 14 million Americans and is characterized by nasal inflammation in the absence of infectious or allergic triggers. When medical management fails, patients may pursue procedural intervention to ablate the posterior nasal nerves. Currently available FDA-cleared standard-of-care options include in-office radiofrequency ablation (RhinAer, Neuromark) and cryotherapy (ClariFix). Despite the availability of these modalities, comparative effectiveness data are lacking. This randomized controlled trial will enroll adult patients and randomly assign them to one of the three treatment arms to compare symptom reduction and durability of response across the three procedures.

Вмешательства

• Устройство RhinAer
  RhinAer is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
• Устройство Neuromark
  Neuromark is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
• Устройство Clarifix
  ClariFix is an in-office cryoablation device that applies freezing (cold thermal) energy to the posterior nasal nerve in the posterior nasal cavity. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.

Первичные конечные точки

• Sino-Nasal Outcome Test-22 (SNOT-22) [Срок оценки: SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure.]
• Total Nasal Symptom Score (TNSS) [Срок оценки: TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.]

Вторичные конечные точки (1)

• Visual Analog Scale (VAS) Patient Satisfaction [Срок оценки: VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.]

Критерии участия

Критерии включения

• Age 18 years or older
• Diagnosis of chronic rhinitis (non-allergic rhinitis)

Критерии исключения

\- Under 18 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Perlman Medical Office at UC San Diego — La Jolla
• Veterans Affairs San Diego Healthcare System — San Diego

Идентификаторы

NCT: NCT07706595 · #810809

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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