NCT07071571尚未招募不适用
Evaluation of the Usability and Safety of the Newly Developed Piezoelectric Sensor Intraoperative Nerve Monitoring Device in Thyroid and Parathyroid Surgery: A Pilot Study
SB Istanbul Education and Research Hospital0 个研究点目标入组 40 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- recurrent nerve identification
研究概览
简要总结
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries.
详细描述
This study is testing a new device developed to protect the recurrent laryngeal nerve, which is at risk of damage during thyroid and parathyroid surgeries. Such devices are still used in surgical routine, but research has been initiated on this subject due to the higher sensitivity and reliability of this new device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70, diagnosis of benign/malignant thyroid disease, informed consent
排除标准
- •History of previous nerve injury, concomitant neurological disorder
结局指标
主要结局
recurrent nerve identification
时间窗: introperatively
nerve will be identified with new device
次要结局
未报告次要终点
研究者
Erhan Aysan
Prof Dr
SB Istanbul Education and Research Hospital
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