NCT05426213撤回不适用
A Real-World Study to Evaluate the Effectiveness and Safety of Robot-Assisted Bronchoscopy in Chinese Patients With Lung Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Navigation Success Rate
研究概览
简要总结
Robot-assisted bronchoscopy biopsy procedure will be conducted for all eligible subjects under general anesthesia status by trained investigators in hospital.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable and willing to give informed consent
- •Acceptable candidate for an elective, non-emergency bronchoscopic procedure
- •Lung lesions suspected of malignancy, between 8-50 millimeters (mm) in diameter size identified on thin slice (0.9-1.25 mm) computed tomography (CT) scan within 14 days, requiring bronchoscopic biopsy for diagnosis
- •No more than 1 lung lesion will be targeted for robot-assisted bronchoscopy biopsy
排除标准
- •Pre-Operative
- •Participants with pure ground-glass opacity lesions on pre-procedure chest CT
- •Participants with the target lesion having endobronchial involvement seen on chest CT
- •Medical contraindications to bronchoscopy and/or anesthesia as assessed by the investigator (such as severe cardiac arrhythmias, severe hypertension, severe cardiopulmonary dysfunction, myocardial infarction, unstable angina pectoris et cetera [etc]) precluding safe bronchoscopic procedure
结局指标
主要结局
Navigation Success Rate
时间窗: Intraoperative
Navigation success rate is defined as the percentage of successful navigation to the targeted lung lesion (lesion localization) as confirmed by radial probe endobronchial ultrasound (R-EBUS) imaging through Monarch Platform during bronchoscopy procedure.
次要结局
- Total Procedure Time(Intraoperative)
- Time to R-EBUS Confirmation(Intraoperative)
- Number of Conversion to Conventional Bronchoscopic Procedure(Intraoperative)
- Time to the Tissue Acquisition(Intraoperative)
- Number of Participants with Pneumothorax Requiring Intervention(Up to 7 days post procedure)
- Number of Participants with Device or Procedure Related Respiratory Failure(Up to 7 days post procedure)
- Number of Participants with Device or Procedure Related Bleeding Requiring Medical Intervention(Up to 7 days post procedure)
研究者
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