A Study of the Safety and Effectiveness of a Compound Steep-Pulse Therapy Apparatus for Malignant Liver Tumors

Prior treatment

• 4.Previous ablation of the target lesion. Newly developed lesions adjacent to a previously ablated target lesion may be eligible.
• 13.Participation in another drug or medical device trial without having exited that trial before enrollment.

Other illness

• 1.Severe dysfunction of major organs, such as the heart, lungs, or kidneys, that, in the investigator's judgment, would preclude tolerance of treatment.
• 3.Allergy to contrast agents used for CT or MRI.
• 8.Severe portal hypertension or a history of esophageal variceal bleeding within the past month.
• 9.An implanted cardiac pacemaker or a metallic implant within 2.5 cm of the ablation zone.
• 10.A history of epilepsy.
• 11.A history of severe arrhythmia within the past month that could not be controlled with medication.
• 14.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this clinical trial.

Lab values

• 6.Severe coagulation abnormalities, defined as a platelet count <50 × 10⁹/L or prolongation of prothrombin time by >5 seconds.

Other

• 2.Contraindications to general anesthesia.
• 5.Imaging evidence of invasion of major blood vessels or bile ducts on liver CT, MRI, or other imaging examinations.
• 7.Uncorrectable refractory massive ascites or cachexia.
• 12.Pregnancy, breastfeeding, or plans to conceive during the study.

• 1.Age ≥18 and ≤80 years, regardless of sex.
• 2.Diagnosed with a malignant liver tumor.
• 3.Child-Pugh class A or B liver function.
• 4.A single tumor ≤4 cm in diameter, or up to three tumor lesions, each with a maximum diameter ≤3 cm.
• 5.Willing to participate in the study and voluntarily provide written informed consent.
• 6.Expected survival >6 months.