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
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
RECRUITING
Hangzhou
Shandong Public Health Clinical Center
RECRUITING
Jinan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai Chest Hospital
RECRUITING
Shanghai
Zhongshan Hospital，Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xiaoxuan Zheng
milozheng9140@163.com
18930859598
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 186
Treatments
Experimental: RAB group
The eligible patient will be diagnosed using the robotic bronchoscopy system and catheters developed by Changzhou Langhe Medical Devices Co., Ltd.
Active_comparator: UB-VBN group
The eligible patient will be diagnosed using ultrathin bronchoscope combined with virtual bronchoscopic navigation.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Chest Hospital