Health TrialsbyHealthPanel

AI-Driven Autonomous Registration in Robotic Bronchoscopy

ConditionsLung NodulesBronchoscopyLocalization Efficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Autonomous registration groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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