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.