unicorn robotic bronchoscopy system
Procedurecryobiopsy with the help of robotic bronchoscopy system
NCT Number: NCT06832930
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 .
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
cryobiopsy with the help of robotic bronchoscopy system
cryobiopsy with the help of Conventional navigation bronchoscopy
Time frame: 6 months after biopsy
Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.
Time frame: During the bronchoscopy
The success rate of navigation = (the number of lesions judged as successfully navigated / the total number of lesions undergoing transbronchial lung biopsy) * 100%. The criteria for judging successful navigation: if the lesion edge is confirmed by imaging equipment and the researcher deems it feasible for biopsy, it is considered a successful navigation; otherwise, it is regarded as a failed navigation. For those with a clear diagnosis through the research procedure, all are considered successful navigation.
Contact information is provided by the study sponsor or research team.
Guangzhou Medical University
Other
A Real-World Case Study Evaluating the Efficacy and Safety of Bronchial Navigation Localization Device-Assisted Cryobiopsy
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