NCT03739216已完成不适用
A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 22
- 主要终点
- Change from baseline in nasal symptom severity
研究概览
简要总结
A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use.
- •Participant is able to provide consent and willing to adhere to the study visit schedule.
排除标准
- •Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
- •Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.
结局指标
主要结局
Change from baseline in nasal symptom severity
时间窗: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12.
次要结局
- Patient-assessed improvement in nasal symptoms(Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment)
- Clinician-assessed improvement in nasal symptoms(Follow-up visit at 3 months post treatment)
研究者
研究点 (22)
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