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NOT YET RECRUITING
NCT06832930
NA

A Real-World Case Study Evaluating the Efficacy and Safety of RBS Cryobiopsy

Sponsor: Guangzhou Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are: Does RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes. Participants will: Provide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion. Be monitored for immediate and delayed complications .

Official title: A Real-World Case Study Evaluating the Efficacy and Safety of Bronchial Navigation Localization Device-Assisted Cryobiopsy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-02-15

Completion Date

2025-12-31

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

PROCEDURE

unicorn robotic bronchoscopy system

cryobiopsy with the help of robotic bronchoscopy system

PROCEDURE

Conventional navigation bronchoscopy

cryobiopsy with the help of Conventional navigation bronchoscopy