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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
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.
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Autonomous registration success rate
Proportion of registrations completed independently by the AI algorithm without manual intervention.
Time frame: Intraoperative
Manual intervention rate during autonomous registration
The proportion of cases requiring manual adjustment by the physician during the registration process.
Time frame: Intraoperative
Time consumed for autonomous registration
Time frame: Intraoperative
Complication rate during autonomous registration
Complication rate during autonomous registration (e.g., bleeding, pneumothorax)
Time frame: Immediate post-procedure to 24 hours
Localization success rate of pulmonary nodules
The proportion of successful bronchoscope arrivals at the target nodule after registration.
Time frame: Intraoperative
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