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

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.

NCT Number	NCT06832956
Lead Sponsor	Guangzhou Medical University
Conditions	Lung Cancer Patients
Enrollment	10 participants
Start Date	2025-02-15
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-18