Feasibility Evaluation of the OtoSet - Ear Cleaning System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SafKan
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Safety as Assessed by Adverse Events
研究概览
简要总结
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
详细描述
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.
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
- 否
入选标准
- •Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
- •Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- •Subject has life threatening illness
- •Subject has immune deficiency
结局指标
主要结局
Safety as Assessed by Adverse Events
时间窗: Treatment Visit (Day 1) through follow-up call (Day 2-4)
Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening)
Efficacy as Assessed by Occlusion Scale
时间窗: Treatment Visit (Day 1) (pre- to post-procedure)
Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion)
次要结局
未报告次要终点