RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

NCT ID: NCT06962436

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-12-31

Brief 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 184 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 diagnostic yield. Secondary endpoints include navigation success yield, arrival time, and incidence of complications.

Conditions

Peripheral Pulmonary Nodules

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

RAB group

The eligible patient will be diagnosed using the robotic bronchoscopy system and catheters developed by Changzhou Langhe Medical Devices Co., Ltd.

Group Type: EXPERIMENTAL

Robotic bronchoscopy system

Intervention Type: DEVICE

Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

UB-VBN group

The eligible patient will be diagnosed using ultrathin bronchoscope combined with virtual bronchoscopic navigation.

Group Type: ACTIVE_COMPARATOR

Ultrathin bronchoscope combined with virtual bronchoscopic navigation

Intervention Type: DEVICE

Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

Interventions

Robotic bronchoscopy system

Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiayuan Sun

Deputy Hospital Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayuan Sun

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

Shandong Public Health Clinical Center

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Xiaoxuan Zheng

Role: CONTACT

milozheng9140@163.com

18930859598

Facility Contacts

Xiaopin Wang, PhD

Role: primary

jinan5823@126.com

86-0531-86568019

Wei CHEN, PHD

Role: primary

cw11242@rjh.com.cn

021-64370045

Chun Li, MD

Role: primary

li.chun@zs-hospital.sh.cn

86-21-64041990

Enguo Chen, PhD

Role: primary

3195024@zju.edu.cn

0571-87887890

Other Identifiers

SHCHE202503

Identifier Type: -

Identifier Source: org_study_id