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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Hecheng Li, M.D., Ph.D.
lihecheng2000@hotmail.com
+021 64370045
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov