NCT01474005Unknown不适用
Establishment of an Artificial Larynx After Total Laryngectomy
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Evaluation of the restoration of respiratory functions
研究概览
简要总结
This study aims to evaluate the effectiveness of an artificial larynx on the restoration of laryngeal functions, mainly breathing and swallowing.
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
- •Anyone over 18 years, male or female, with a carcinomatous disease of the upper airways requiring a total laryngectomy
排除标准
- •Less than 18 years
- •Contraindications to general anesthesia
- •Any situation considered by the physician operator as an exclusion
- •Pregnant women
- •Lactating women
- •Subglottic or basi-lingual tumor extension more than 1 cm
- •Prior radiotherapy
- •Severe coagulation disorders
结局指标
主要结局
Evaluation of the restoration of respiratory functions
时间窗: one year
4 items will be used: * 0: no dyspnea * 1: moderate dyspnea * 2: significant dyspnea * 3: major dyspnea
Evaluation of the restoration of the ability to swallow by nasofibroscopy
时间窗: one year
3 items will be used: * 1: no aspiration * 2: moderate aspiration * 3: massive aspiration
次要结局
未报告次要终点
研究者
研究点 (2)
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