This prospective, single-center clinical study will evaluate whether an 18-gauge ultrafine cryoablation needle can be used feasibly and safely during CT-guided coaxial transthoracic biopsy of pulmonary nodules. Approximately 30 adults with pulmonary nodules highly suspected of malignancy who are unsuitable for or decline surgery or radiotherapy will undergo biopsy and cryoablation during the same procedure. The study will assess technical success, biopsy diagnostic performance, imaging-based local control, and device- or procedure-related adverse events. Participants will be followed for up to 36 months. The study hypothesis is that the same-tract procedure is technically feasible and provides acceptable safety and local disease control.
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.
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.
Single group
18G Ultrafine Cryoablation Needle
DeviceAn ultrafine cryoablation needle used for image-guided local ablation of pulmonary nodules. Treatment parameters are individualized according to lesion characteristics.
Technical success rate
Percentage of treated target lesions for which immediate post-ablation imaging shows an ablation zone extending at least 5 mm beyond the target lesion boundary.
Diagnostic yield
Percentage of biopsied lesions yielding a diagnostic histopathologic result
Biopsy specimen quality
Comparison of pre-ablation and post-ablation specimens using specimen quality with a modified 5-point Likert scale (point 0-4, The higher the score, the better the sample quality.)
Complete ablation rate
Percentage of treated lesions meeting the protocol-defined imaging criteria for complete ablation.
Local control rate
Percentage of treated lesions without local progression at each scheduled time point.
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