NCT01611246已完成不适用
Performance of the Acclarent Iontophoresis System With Earset (IPSES) in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of subjects anesthetized as assessed by Wong-Baker scale
研究概览
简要总结
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
研究设计
- 研究类型
- Observational
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
- 是
入选标准
- •At least 12 months old
排除标准
- •Pregnant or lactating females
- •Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
- •Significantly atrophic or perforated tympanic membrane
- •Otitis externa
- •Damaged or denuded skin in the auditory canal
- •Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- •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
Number of subjects anesthetized as assessed by Wong-Baker scale
时间窗: Day 1
次要结局
- Number of participants with serious adverse events(Day 1)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Healthy Volunteer StudyAnesthesia of Tympanic MembraneNCT01346332Integra LifeSciences Corporation106
进行中（未招募）
不适用
Real World Registry for Use of the Ion Endoluminal SystemMultiple Pulmonary NodulesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung CancerNCT06004440Intuitive Surgical1,301
已完成
1 期
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.HealthyNCT00280358Dey30
已完成
1 期
Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive SolutionBlood DonorsNCT02145507Haemonetics Corporation170
已完成
不适用
Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy SystemLung CancerNCT05867953Intuitive Surgical200