CClinicalTrials.gg
RecruitingNCT07368829Updated Apr 13, 2026

AI-Driven Autonomous Registration in Robotic Bronchoscopy

An interventional study of AI-driven autonomous registration in Lung Nodules, Bronchoscopy and Localization Efficiency, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Nodules
  • Bronchoscopy
  • Localization Efficiency

Keywords

  • Artificial Intelligence
  • Robotic Bronchoscopy
  • Pulmonary Nodule
03

In context

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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.

    Device: AI-driven autonomous registration

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.

06

What researchers measure

Primary outcomes

  1. Autonomous registration success rate

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

    Time frame: Intraoperative

  2. Manual intervention rate during autonomous registration

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

    Time frame: Intraoperative

Secondary outcomes

  1. Time consumed for autonomous registration

    Time frame: Intraoperative

  2. Complication rate during autonomous registration

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

    Time frame: Immediate post-procedure to 24 hours

  3. Localization success rate of pulmonary nodules

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

    Time frame: Intraoperative

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07368829
Lead sponsor
Ruijin Hospital
Responsible party
Hecheng Li M.D., Ph.D (Director, Department of Thoracic Surgery, Ruijin Hospital, Ruijin Hospital) — Principal investigator
First posted
Jan 27, 2026
Start date
Mar 1, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 13, 2026

Study contacts

Hecheng Li, M.D., Ph.D.
Contact
lihecheng2000@hotmail.com
+021 64370045

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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