RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
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
Shanghai Chest Hospital
186 participants
Jul 2, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years, regardless of gender;
- Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
- Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
- 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 Criteria7
- 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;
- Patients with pure ground-glass nodules suspected of malignancy on chest CT;
- Female patients who are breastfeeding, pregnant, or planning pregnancy;
- Patients with electromagnetic active implantable medical devices;
- Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
- 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;
- Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
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Interventions
Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06962436