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NCT Number: NCT07368829

AI-Driven Autonomous Registration in Robotic Bronchoscopy

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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Key information

Conditions

Lung Nodules Bronchoscopy Localization Efficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Hecheng Li

CONTACT

[email protected]

+021 64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Autonomous registration success rate

    Time frame: Intraoperative

    Proportion of registrations completed independently by the AI algorithm without manual intervention.

  2. Manual intervention rate during autonomous registration

    Time frame: Intraoperative

    The proportion of cases requiring manual adjustment by the physician during the registration process.

Secondary outcomes

  1. Time consumed for autonomous registration

    Time frame: Intraoperative

  2. Complication rate during autonomous registration

    Time frame: Immediate post-procedure to 24 hours

    Complication rate during autonomous registration (e.g., bleeding, pneumothorax)

  3. Localization success rate of pulmonary nodules

    Time frame: Intraoperative

    The proportion of successful bronchoscope arrivals at the target nodule after registration.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+021 64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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