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

NCT06832930 · Guangzhou Medical University · Updated 18 Feb 2025

What is being tested
unicorn robotic bronchoscopy system; Conventional navigation bronchoscopy
For
Peripheral Pulmonary Lesion
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 75 years. About 200 people. The full rules are on the registry page.
Where
Not stated
When
Starts or started 15 Feb 2025, ends 31 Dec 2025. Registered 18 Feb 2025.
Results
None posted yet.

In the researchers' words

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 .
ClinicalTrials.gov, NCT06832930