NCT01948219终止不适用
An Evaluation of the ENTegral Artificial Larynx (AL) in Patients Indicated for Total Laryngectomy
ProTiP Medical6 个研究点 分布在 2 个国家目标入组 2 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Feasibility of device implant procedure
研究概览
简要总结
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.
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
- •Age more than or equal to 18 years old
- •Is indicated for total laryngectomy (first intention)
- •Must be able to comply with study requirements
- •Must be able to understand and be willing to provide written informed consent
排除标准
- •Any condition that precludes the implantation of the ENTegral AL
- •Existing coagulation disorder
- •Contraindication for general anesthesia
- •Tumoral extension outside of the larynx invading through extra-laryngeal structures
- •Previous radiotherapy
- •Life-expectancy < 12 months
- •Be pregnant of breastfeeding or intention to becoming pregnant during study
研究组 & 干预措施
ENTegral Artificial Larynx implant
Experimental
ENTegral Artificial Larynx implantation
干预措施: ENTegral Artificial Larynx implant (Device)
结局指标
主要结局
Feasibility of device implant procedure
时间窗: 1 year
Number of patients with adverse event associated with device implantation procedure
次要结局
未报告次要终点
研究者
研究点 (6)
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