Feasibility and Safety of Artificial Intelligence-Driven Autonomous Registration in Robotic Navigational Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Autonomous registration success rate
研究概览
简要总结
This study aims to evaluate the feasibility and safety of an artificial intelligence (AI)-driven autonomous registration technology in robotic navigational bronchoscopy. A total of 20 patients with pulmonary nodules requiring localization will be enrolled. The Langhe Bronchoscopy Robot System equipped with AI-based autonomous registration software will be used. Primary outcomes include the success rate of autonomous registration and the rate of manual intervention during the process. Secondary outcomes encompass registration time, complication rates, and nodule localization success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age ≥ 18 years.
- •Radiologically confirmed pulmonary nodules requiring preoperative localization.
- •Scheduled for robotic navigational bronchoscopy using the Bronchoscopy Robot System.
- •Willing to provide written informed consent.
排除标准
- •Severe cardiopulmonary dysfunction (e.g., FEV1 < 30% predicted).
- •Coagulopathy or anticoagulation therapy that cannot be safely interrupted.
- •Pregnancy or lactation.
- •Inability to tolerate bronchoscopy under general anesthesia.
研究组 & 干预措施
Autonomous registration group
All participants in this arm will undergo robotic navigational bronchoscopy and pulmonary nodule localization performed using the Langhe Bronchoscopy Robot System. The key intervention is the use of artificial intelligence (AI)-driven autonomous registration technology to automatically align the pre-operative chest CT images with the real-time bronchoscopic anatomy prior to the procedure. This process aims to reduce reliance on the conventional, operator-dependent manual registration. Physicians will supervise the entire process and perform necessary manual intervention if the AI registration is unsatisfactory or for safety reasons.
干预措施: AI-driven autonomous registration (Device)
结局指标
主要结局
Autonomous registration success rate
时间窗: Intraoperative
Proportion of registrations completed independently by the AI algorithm without manual intervention.
Manual intervention rate during autonomous registration
时间窗: Intraoperative
The proportion of cases requiring manual adjustment by the physician during the registration process.
次要结局
- Time consumed for autonomous registration(Intraoperative)
- Complication rate during autonomous registration(Immediate post-procedure to 24 hours)
- Localization success rate of pulmonary nodules(Intraoperative)
研究者
Hecheng Li M.D., Ph.D
Director, Department of Thoracic Surgery, Ruijin Hospital
Ruijin Hospital