RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

NCT06962436 | Recruiting DMC

• 1 other identifier: SHCHE202503
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 5

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.

Conditions

Peripheral Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Intermediate definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis+Number of procedures with nonspecific benign diagnoses that turn out to be nonmalignant at follow-up)/Total number of patients in whom the minimally invasive procedure was attempted or performed\*100%

  14 days post-procedure

Secondary Outcomes (4)

• Navigation success yield

  During the procedure

• Navigation time

  During the procedure

• Incidence of complications

  14 days post-procedure

• Strict definition of diagnostic yield

  14 days post-procedure

Study Arms (2)

RAB group

EXPERIMENTAL

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

Device: Robotic bronchoscopy system

UB-VBN group

ACTIVE COMPARATOR

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

Device: Ultrathin bronchoscope combined with virtual bronchoscopic navigation

Interventions

Robotic bronchoscopy system DEVICE

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

RAB group

Ultrathin bronchoscope combined with virtual bronchoscopic navigation DEVICE

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

UB-VBN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (5)

Shandong Public Health Clinical Center

Jinan, Shandong, 250000, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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

Hangzhou, Zhejiang, 310016, China

RECRUITING

Study Officials

• Jiayuan Sun

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaoxuan Zheng

CONTACT

18930859598; milozheng9140@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Hospital Director

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)