About this trial
Using RBS as the navigation and treatment platform, precisely navigate to the target lesion. Utilize r-EUBS and nCLE to identify the lesion, and when the confocal AI model recognizes the lesion as malignant, perform a biopsy. Subsequently, under the guidance of OBCT, carry out ablation treatment of the lesion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years, male or female.
High-risk pulmonary nodule/tumor maximum diameter ≤3 cm.
Lesion judged suitable for bronchial navigation-guided diagnosis and treatment.
Ineligible for surgery or refuses surgery/radiotherapy; agrees to primary ablation therapy; provides written informed consent.
Disqualifiers
Diffuse bilateral lung lesions unresponsive to ablation.
Contraindication to bronchoscopy or inability to tolerate/cooperate with bronchoscopy.
Severe bleeding tendency or irreversible coagulopathy (PT >18 s, PTA <40%).Platelet count <70×10⁹/L; anticoagulant/antiplatelet therapy discontinued <1 week before ablation (except prophylactic low-molecular-weight heparin).
Severe pulmonary impairment (maximal voluntary ventilation <40%).
Trial design
Single group
Treatments tested in this trial
Ablation
Procedure/SurgeryUsing RBS, nCLE, r-EBUS, OBCT and Cryoablation or Radiofrequency ablation for lung cancer
Treatment groups
Trial outcomes
Primary outcomes
Integrated completion rate of detection, sampling and treatment
Integrated completion rate of detection, sampling and treatment= (Number of cases with successful integrated detection, sampling and treatment / Total enrolled cases) × 100% Definition of integrated success: Under the guidance of the bronchial navigation and positioning system, the lesion is confirmed by radial endobronchial ultrasound (r-EBUS) or CBCT; imaging diagnosis is obtained via probe-based confocal laser endomicroscopy (pCLE); qualified tissue samples are successfully collected; and local treatment is completed.
Secondary outcomes
Diagnostic success rate
Diagnostic success rate = (Number of cases with definite pathological diagnosis / Total enrolled cases) × 100% Definition of definite pathological diagnosis: Malignant lesions Specific benign lesions: tuberculosis, fungal infection, granulomatous lesions, organizing pneumonia, etc.
Locations
Sponsors and contacts
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