18G Ultrafine Cryoablation Needle for Coaxial Biopsy and Cryoablation of Pulmonary Nodules

Inclusion Criteria: * Age 18 years or older. * One or more pulmonary nodules measuring 3 cm or less on chest CT and considered highly suspicious for malignancy after multidisciplinary review. * The participant is unsuitable for or declines surgery and radiotherapy after multidisciplinary evaluation and shared decision-making. * A safe percutaneous access route is available, and the planned ablation zone can cover the target lesion. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Expected survival of at least 12 months. * The participant or legally authorized representative voluntarily provides written informed consent. Exclusion Criteria: * Platelet count below 50 × 10\^9/L, clinically significant bleeding tendency, or uncorrectable coagulation disorder. * Severe pulmonary fibrosis, pulmonary hypertension, or other severe cardiac, pulmonary, hepatic, renal, neurologic, or systemic organ dysfunction that makes the procedure unsafe. * Uncontrolled local or systemic infection, including uncontrolled infection near the lesion or access site, or fever above 38.5°C. * Poorly controlled malignant pleural effusion. * Anticoagulant or antiplatelet therapy cannot be safely managed before the procedure according to institutional policy. * Pregnancy or a plan to become pregnant during the study. * Active serious psychiatric illness that may interfere with informed consent or study participation. * Participation in another clinical study within 30 days before enrollment. * Any other condition that, in the investigator's judgment, makes participation inappropriate.