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Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer

Guangzhou Medical University · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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The goal of this single-arm clinical trial is to evaluate the safety and efficacy of robotic bronchoscopy system (RBS)-assisted cryoablation in the treatment of primary lung cancer in adult patients (aged ≥18 years) with histologically confirmed non-resectable primary lung cancer, regardless of gender. The main questions it aims to answer are: Does RBS-assisted cryoablation achieve a predefined target technical success rate for complete tumor ablation under imaging guidance? Is the incidence of severe procedure-related adverse events within an acceptable safety threshold ? Participants will: Provide written informed consent for RBS-assisted cryoablation. Undergo pretreatment evaluations, including: Multimodal imaging (CT/PET-CT) for tumor localization and staging. Pulmonary function tests and cardiopulmonary risk assessment. Receive RBS-guided cryoablation therapy under general anesthesia. Be monitored for intraoperative complications and postoperative adverse events for 72 hours. Complete follow-up assessments at 1, 3, 6, and 12 months post-procedure, including: Contrast-enhanced CT scans to evaluate local tumor control. Documentation of symptom progression and quality-of-life metrics.
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