Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07368829

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

Led by Ruijin Hospital · Updated on 2026-04-13

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility and safety of an artificial intelligence (AI)-driven autonomous registration technology in robotic navigational bronchoscopy for patients with pulmonary nodules needing localization. The study will enroll 20 patients to assess how well this AI system aligns pre-operative chest CT images with real-time bronchoscopic anatomy, aiming to reduce the need for manual registration by physicians. The main goals include measuring the success of the AI registration and how often manual help is needed during the process. All participants will undergo robotic navigational bronchoscopy and nodule localization using the Langhe Bronchoscopy Robot System equipped with the AI-based autonomous registration software. Physicians will oversee the procedure and intervene manually if the AI registration does not meet safety or quality standards. This approach focuses on improving the registration process before the bronchoscopic procedure begins. Participants will be closely monitored during and after the procedure with assessments of registration success, time used for registration, any complications within 24 hours, and success in localizing nodules. The study involves collecting data during the operation and immediately afterward to evaluate the AI system's performance and safety. Total study participation includes the procedure and short-term follow-up to check for complications and outcomes.

CONDITIONS

Brief Title

AI-Driven Autonomous Registration in Robotic Bronchoscopy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Single procedure visit

Participants undergo robotic navigational bronchoscopy with AI-driven autonomous registration to localize pulmonary nodules using the Langhe Bronchoscopy Robot System. Physicians supervise the process and may manually intervene if needed for safety or registration issues.

1 procedure visit (in-person)

Trial Site Locations

Total: 1 location

1

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

Actively Recruiting

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Research Team

H

Hecheng Li, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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