Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Incidence of Unanticipated Serious Adverse Device Effects
研究概览
简要总结
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
详细描述
This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with history of Chronic nasal obstruction and Poor nasal breathing
排除标准
- •Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
结局指标
主要结局
Incidence of Unanticipated Serious Adverse Device Effects
时间窗: 90 Days
The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
时间窗: Procedure, up to 1 hour (average, 16 minutes)
Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.
次要结局
未报告次要终点