NCT02262247已完成不适用
A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
研究概览
简要总结
The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 22 years of age
- •Candidate for transoral surgery in the oropharynx, hypopharynx and larynx
排除标准
- •Less than 22 years of age
- •Not a candidate for transoral surgery in the oropharynx, hypopharynx and larynx
结局指标
主要结局
Access and Visualizaton in Oropharynx, Hypopharynx and Larynx
时间窗: Intra-Operative
Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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