NCT01587664终止不适用
Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
ProTiP Medical2 个研究点 分布在 2 个国家目标入组 2 人开始时间: 2012年5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
- 2
- 主要终点
- Aspiration score at 1 month
研究概览
简要总结
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
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 > 18 years old
- •Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
- •Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
- •Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
- •Must be able to understand and be willing to provide written informed consent
排除标准
- •Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
- •Major swallowing disorder
- •Existing coagulation disorder
- •Previous esophageal stenting
- •Life-expectancy < 12 months
- •Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment
研究组 & 干预措施
NewBreez ILP
Experimental
Implantation of a NewBreez ILP
干预措施: NewBreez ILP (Device)
结局指标
主要结局
Aspiration score at 1 month
时间窗: 1 month
Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study
次要结局
未报告次要终点
研究者
研究点 (2)
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