Self-driving Robotic-assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
This is a single-center, prospective, and single-arm study. The purpose of this study is to evaluate the feasibility and safety of a new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary nodules.
详细描述
Self-driving robotic-assisted bronchoscope (Shanghai MicroPort MedBot (Group) Corporation Limited, China) is a new robotic-assisted bronchoscopic system that can automatically advance through airway according to the preoperative planning path under the guidance of electromagnetic navigation. It can also be controlled manually by the operator. In this study, 30 patients will be prospectively enrolled to evaluate the feasibility and safety of this new self-driving robotic-assisted bronchoscopic system for the diagnosis of peripheral pulmonary nodules.
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
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
- •Patients older than 18 years old.
- •Presence of a peripheral pulmonary nodule (8 mm < diameter ≤ 30 mm) on thin-section chest CT that is suspected to be malignant and requires non-surgical biopsy.
- •Patients have good medical adherence and signed informed consent.
排除标准
- •Presence of contraindications to bronchoscopy under general anesthesia.
- •Presence of concomitant endobronchial lesion during the bronchoscopy procedure.
- •The investigators believe that patient has other conditions that are not suitable for the study.
结局指标
主要结局
Complication rate
时间窗: 1 month
The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.
次要结局
- Navigation success rate(1 month)
- Rate of rEBUS confirmation(During the procedure)
- Total examination time(During the procedure)
- Navigation time(During the procedure)
- Duration of finding lesions(During the procedure)
- Diagnostic yield(1 month)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital