NCT01045057已完成不适用
Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Success Rate of Procedure
研究概览
简要总结
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary puncture during total laryngectomy
- •secondary puncture some time after total laryngectomy
排除标准
- •anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
- •not eligible to use a voice prosthesis for other reasons
研究组 & 干预措施
Puncture Set and Flexible Protector
Experimental
Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
干预措施: Puncture Set and Flexible Protector (Device)
结局指标
主要结局
Success Rate of Procedure
时间窗: immediate observation during surgery
As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
次要结局
- Satisfaction of Physician(1 month)
- Postoperative Results(1 month)
- Cost Effectiveness Calculation(1 month)
研究者
研究点 (5)
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