NCT06962436

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.

Conditions

• Peripheral Pulmonary Nodules

Interventions

Type	Name	Description
DEVICE	Robotic bronchoscopy system	Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
DEVICE	Ultrathin bronchoscope combined with virtual bronchoscopic navigation	Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

Timeline

• Start date: 2025-07-02
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-05-08
• Last updated: 2026-03-25

Locations

5 sites across 1 country: China