NCT00213863Unknown2 期
Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Nasofibroscopy
研究概览
简要总结
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.
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
- •Males or females greater than 18 years old
排除标准
- •Age less than 18 years
- •Pregnant women
- •Local carcinoma excluding radiotherapeutic or surgical control
- •Bad general condition
- •Contraindication to general anesthesia
- •Non-controlled diabetes
结局指标
主要结局
Nasofibroscopy
时间窗: 8 days and 3 months after surgery
Voice control and recording
时间窗: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
All types of complication
时间窗: 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial
次要结局
未报告次要终点
研究者
研究点 (1)
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