Clinical Evaluation of Cryotherapy in the Nasal Passageway Using the ClariFix Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Device- and/or Procedure-related Serious Adverse Events
研究概览
简要总结
This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.
详细描述
This is a small, prospective, multicenter, single-arm, self-controlled interventional feasibility study to evaluation cryoablation in the nasal passage as a treatment for chronic rhinitis. The ClariFix device is FDA-cleared device with the intended use for the destruction of unwanted tissue during surgical procedures, including in adults with 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >21 years of age
- •Subject has had moderate to severe symptoms of rhinorrhea and/or nasal congestion for >3 months (rTNSS rating of 2 or 3)
- •Subject has signed IRB-approved informed consent form
排除标准
- •Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
- •Subject has a septal perforation
- •Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
- •Subject has had prior head or neck irradiation
- •Subject has active or chronic nasal or sinus infection
- •Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
- •Subject has a history of dry nose symptoms
- •Subject is pregnant or lactating
- •Subject is participating in another clinical research study
- •Subject has an allergy or intolerance to anesthetic agent
- •Subject is an active smoker or has been a smoker within the last 6 months
- •Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
研究组 & 干预措施
Intervention
Cryoablation with the ClariFix device
干预措施: ClariFix device (Device)
结局指标
主要结局
Device- and/or Procedure-related Serious Adverse Events
时间窗: Baseline through 365 days post treatment
Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.
Change in Rhinitis Symptom Severity (rTNSS)
时间窗: Baseline through 365 days post treatment
Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.
Change in Rhinitis Symptoms (VAS)
时间窗: Baseline through 365 days post treatment
Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.
次要结局
- Device- and/or Procedure-related Adverse Events(Baseline through 90 days post treatment)
- Ease of Use(Immediately post treatment)