NCT03791489已完成不适用
Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
研究概览
简要总结
Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for >3 months.
- •Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
- •Able to provide informed consent and willing to complete study activities and visits per protocol.
排除标准
- •Clinically significant anatomic obstructions that limit access to the posterior nose.
- •Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- •Moderate to severe ocular symptoms as determined.
- •History of epistaxis in the past 3 months.
- •History of rhinitis medicamentosa.
- •Prior head or neck irradiation.
- •Active or chronic nasal or sinus infection.
- •Pregnant.
- •Allergy or intolerance to anesthetic agent.
- •Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
- •Currently participating in another clinical research study.
- •Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.
结局指标
主要结局
Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)
时间窗: Study duration (90-days)
The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.
次要结局
- Pain Scores(Day of treatment during procedure and for up to 1 hour post procedure)
- Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)(30 and 90 days after treatment)
- Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score(30 and 90 days after treatment)
研究者
研究点 (6)
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