A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (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.