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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autonomous registration group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-driven autonomous registration | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomous registration success rate | Proportion of registrations completed independently by the AI algorithm without manual intervention. | Intraoperative |
| Manual intervention rate during autonomous registration | The proportion of cases requiring manual adjustment by the physician during the registration process. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time consumed for autonomous registration | Intraoperative | |
| Complication rate during autonomous registration | Complication rate during autonomous registration (e.g., bleeding, pneumothorax) | Immediate post-procedure to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hecheng Li, M.D., Ph.D. | Contact | +021 64370045 | lihecheng2000@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Localization success rate of pulmonary nodules | The proportion of successful bronchoscope arrivals at the target nodule after registration. | Intraoperative |