Radiofrequency Ablation (RhinAer, Neuromark) vs. Cryoablation (ClariFix) of the Posterior Nasal Nerve for Chronic Rhinitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sino-Nasal Outcome Test-22 (SNOT-22)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of chronic rhinitis (non-allergic rhinitis)
排除标准
- •- Under 18 years of age
结局指标
主要结局
Sino-Nasal Outcome Test-22 (SNOT-22)
时间窗: SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure.
SNOT-22 is a validated 22-item patient-reported outcome measure assessing sinonasal-specific quality of life across domains including nasal symptoms (nasal blockage, rhinorrhea, loss of smell/taste), ear and facial symptoms (ear pain, facial pressure), sleep dysfunction (difficulty falling asleep, waking up tired), and psychological and functional impairment (reduced productivity, fatigue, sadness).
Total Nasal Symptom Score (TNSS)
时间窗: TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure.
TNSS is a validated 4-item patient-reported scoring instrument measuring severity of rhinorrhea, nasal congestion, nasal itching, and sneezing.
次要结局
- Visual Analog Scale (VAS) Patient Satisfaction(VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure.)
研究者
Carol Yan
Associate Professor Of Clinical, Otolaryngology
University of California, San Diego