NCT04139889Unknown不适用
The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pCLE diagnostic classification
研究概览
简要总结
To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.
详细描述
In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤Male or female age ≤85 years old;
- •patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery;
- •Willing and able to comply with study procedures and provide written informed consent to participate in the study.
排除标准
- •Male or female <18 years old, or Male or female >85 years;
- •The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination;
- •The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery.
- •The patient has a history of allergies to drugs or food.
- •The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein;
- •Lactation or pregnant women.
- •Refusal to sign the informed consent form.
- •Others who do not take this test.
结局指标
主要结局
pCLE diagnostic classification
时间窗: 6 months
Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.
次要结局
- the image analysis by machine learning(6 months)
研究者
研究点 (1)
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