NCT02123277已完成不适用
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Tubal score
研究概览
简要总结
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.
详细描述
The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.
This patients are refractory to the reference medical treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 20 and 80 years old
- •tubal score lower than 5
- •patients who already used reference medical treatment
排除标准
- •patients who already do a major surgery of middle ear
- •tympanic perforation
- •pregnant or breastfeeding woman.
- •patients who can't be follow during 14 months
结局指标
主要结局
Change in Tubal score
时间窗: at 1st day, and 2 months
次要结局
未报告次要终点
研究者
研究点 (2)
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