NCT01047904已完成不适用
Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Procedural Success
研究概览
简要总结
The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.
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
- 是
入选标准
- •>=18 years of age
- •Both male and female subjects are eligible.
排除标准
- •Pregnant or lactating females
- •Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution.
- •Markedly atrophic TM
- •Perforated TM
- •Sclerotic TM
- •Otitis externa
- •Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- •Damaged or denuded skin in the auditory canal
- •Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- •Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
结局指标
主要结局
Procedural Success
时间窗: X days
Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers
次要结局
- Tolerability of the iontophoresis system(X days)
- Incidence of adverse effects associated with the System and the Iontophoresis procedure(X days)
研究者
研究点 (1)
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