Robotic-assisted bronchoscopy versus ultrathin bronchoscopy with virtual navigation for diagnosing peripheral lung nodules

Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study

This trial will test whether robotic-assisted bronchoscopy works as well as ultrathin bronchoscopy with virtual bronchoscopic navigation to diagnose peripheral lung nodules in adults who need a non-surgical biopsy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 5 sites (Jinan, Shandong and 4 other locations)
• Trial ID: NCT06962436 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized non-inferiority trial planning to enroll 186 adults with peripheral pulmonary nodules suspicious for malignancy who require non-surgical biopsy. Participants are randomly assigned to robotic-assisted bronchoscopy using a system developed by Changzhou Langhe Medical Devices or to ultrathin bronchoscopy guided by virtual bronchoscopic navigation, with radial endobronchial ultrasound (r-EBUS) available for all procedures. When the physician judges biopsy sampling feasible, a transbronchial lung biopsy will be performed during the procedure. The primary endpoint is an intermediate definition of diagnostic yield, and secondary endpoints include navigation success yield, time to lesion arrival, complication rates, and a strict diagnostic-yield definition.

Who should consider this trial

Good fit: Adults (age ≥18) with peripheral lung nodules suspicious for malignancy on chest CT who require a non-surgical biopsy and can safely undergo bronchoscopy and provide informed consent.

Not a fit: Patients with contraindications to bronchoscopy—such as active massive hemoptysis, recent unstable cardiac events, severe cardiopulmonary dysfunction, or uncorrectable bleeding disorders—are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could give patients a reliable, less invasive way to get accurate diagnoses of peripheral lung nodules and help guide treatment sooner.

How similar studies have performed: Ultrathin bronchoscopy with virtual navigation and r-EBUS has an established track record for sampling peripheral nodules, and early studies of robotic bronchoscopy have shown promising diagnostic yields but lack large randomized comparisons.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years, regardless of gender;
2. Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
3. Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
4. Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
2. Patients with pure ground-glass nodules suspected of malignancy on chest CT;
3. Female patients who are breastfeeding, pregnant, or planning pregnancy;
4. Patients with electromagnetic active implantable medical devices;
5. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
6. Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
7. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Where this trial is running

Jinan, Shandong and 4 other locations

• Shandong Public Health Clinical Center — Jinan, Shandong, China (Recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhongshan Hospital，Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaoxuan Zheng

Conditions Peripheral Pulmonary Nodules