Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)

Inclusion Criteria: * HCC diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter, * Child-Pugh class A, * Eastern Cooperative Oncology Group (ECOG) score of 0, * American Society of Anaesthesiologists (ASA) score ≤ 3, * a prothrombin time ratio \> 50%, * platelet count \> 50x109/L, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure, * are able to comprehend and willing to sign the written informed consent form (ICF), * have a life expectancy of at least 3 months. Exclusion Criteria: * eligible for surgical treatment or transplantation for HCC, * presence of vascular invasion or extrahepatic metastases, * received previous treatment for HCC, * HCC developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg Pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, * are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.