NCT00576134已完成1 期
Artificial Larynx : Intralaryngeal Prosthesis With Valve in Major Swallowing Troubles
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Respiratory evaluation
研究概览
简要总结
Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age more than 18
- •Swallowing troubles
排除标准
- •Pregnant women
- •Contraindications to general anesthesia
结局指标
主要结局
Respiratory evaluation
时间窗: Day : 1, 2, 3, 4, 5, 15 - month :1, 3, 6, 12, 18, 24, 30, 36
次要结局
- Nasofibroscopy(Day : 15 - month : 1, 3, 6, 12, 18, 24, 30, 36)
研究者
研究点 (2)
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