First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment
研究概览
简要总结
This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 months and older
- •Both male and female patients eligible
- •Patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant)
排除标准
- •Patients 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, retracted, atelectatic or perforated tympanic membrane
- •Otitis externa
- •Electrically sensitive patients and patients 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
结局指标
主要结局
Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment
时间窗: Day 0
Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.
Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).
时间窗: Day 0
次要结局
- Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale(Day 0)
- Subject/Parent Reported Satisfaction With the In-office Procedure(Day 0)