Evaluation of the Safety and Efficacy of a Wideband Electric Pulse Tumor Ablation System for Malignant Pulmonary Nodules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Subjects with malignant pulmonary nodules (confirmed by histopathology) planned for ablation therapy, including:

   1. Stage IA primary non-small cell lung cancer; or
   2. Intrapulmonary metastatic tumors with the primary lesion well controlled.
3. Solitary lesion size ≤ 2 cm, and total number of lesions ≤ 3.
4. ECOG performance status score ≤ 2.

Patients who are ineligible for surgery/radiotherapy, or who refuse surgery/radiotherapy, or who voluntarily participate.

Exclusion Criteria:

A patient will be excluded from participation in this clinical trial if any of the following conditions apply:

1. Severe bleeding tendency, platelet count \< 50×10⁹/L, or coagulation dysfunction (prothrombin time \> 18 s, prothrombin activity \< 40%) that cannot be corrected in the short term.
2. Anticoagulant therapy and/or antiplatelet medications discontinued for less than 1 week prior to ablation.
3. Infectious or radiation-induced inflammation around the lesion, poorly controlled skin infection at the puncture site, systemic infection, or fever \> 38.5°C.
4. Severe dysfunction of the liver, kidney, heart, lung, or brain; severe anemia, dehydration, or serious nutritional/metabolic disorders that cannot be corrected or improved in the short term.
5. Poorly controlled malignant pleural effusion.
6. Distant metastasis of lung cancer.
7. Concurrent other malignancies with extensive metastasis, and expected survival \< 6 months.
8. Presence of implanted electronic devices near the target area, or an implanted cardiac pacemaker or defibrillator.
9. The target lesion has received prior local treatments (e.g., radiotherapy, ablation) within 3 months before enrollment.
10. Participation in any drug and/or medical device clinical trial within 1 month before enrollment.
11. Pregnancy, lactation, or planned pregnancy within one year.
12. Any other condition that the investigator considers inappropriate for enrollment.