NCT03978195Unknown不适用
EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
Yuinvent Innovations Ltd.0 个研究点目标入组 40 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Middle ear values of Tympanometry
研究概览
简要总结
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.
The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.
- •In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).
排除标准
- •First encounter: acute ear infection or Proper Otoscopy
- •Second session: First review: Otoscopy / Timpneometry / Hearing test.
- •Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
研究组 & 干预措施
Control
No Intervention
Treatment
Experimental
干预措施: Non-invasive device for middle ear ventilation (Device)
结局指标
主要结局
Middle ear values of Tympanometry
时间窗: 10 weeks
Values will be compared to baseline values of Tympanometry
Middle ear ventilation evaluated by otoscopy
时间窗: 10 weeks
Otoscopy evaluation of ear ventilation will be compared to baseline values
次要结局
- Auditory test(10 weeks)
研究者
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