AI-driven autonomous registration for robotic bronchoscopy localization
Feasibility and Safety of Artificial Intelligence-Driven Autonomous Registration in Robotic Navigational Bronchoscopy
NA · Ruijin Hospital · NCT07368829
This trial will test whether an AI system can automatically register and help guide robotic bronchoscopy for adults who need pulmonary nodule localization.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07368829 on ClinicalTrials.gov |
What this trial studies
This single-center interventional feasibility study will enroll 20 adult patients with radiologically confirmed pulmonary nodules requiring preoperative localization. Procedures will use the Langhe Bronchoscopy Robot System equipped with AI-based autonomous registration software to attempt automatic registration during robotic navigational bronchoscopy. Primary outcomes are the success rate of autonomous registration and the frequency of required manual intervention; secondary outcomes include registration time, complication rates, and nodule localization success. Safety and feasibility data will be collected perioperatively to characterize performance and any adverse events.
Who should consider this trial
Good fit: Adults (age ≥18) with radiologically confirmed pulmonary nodules scheduled for preoperative robotic navigational bronchoscopy at the participating center who can provide informed consent.
Not a fit: Patients with severe cardiopulmonary dysfunction, uncorrectable coagulopathy or anticoagulation that cannot be safely stopped, pregnancy, lactation, or inability to tolerate general anesthesia are ineligible and unlikely to benefit.
Why it matters
Potential benefit: If successful, the AI registration could reduce procedure time and manual adjustments, making nodule localization faster and potentially safer.
How similar studies have performed: Early pilot studies of AI-assisted navigation in bronchoscopy have reported promising feasibility but larger or randomized validation studies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Hecheng Li, M.D., Ph.D.
- Email: lihecheng2000@hotmail.com
- Phone: +021 64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Nodules, Bronchoscopy, Localization Efficiency, Artificial Intelligence, Robotic Bronchoscopy, Pulmonary Nodule