RecruitingNot ApplicableNCT07368829

AI-Driven Autonomous Registration in Robotic Bronchoscopy

Feasibility and Safety of Artificial Intelligence-Driven Autonomous Registration in Robotic Navigational Bronchoscopy

Sponsor

Ruijin Hospital

Enrollment

20 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Nodules Bronchoscopy Localization Efficiency

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria4

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.

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Interventions

DEVICEAI-driven autonomous registration

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.