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

AngioDynamics

Status

Completed

Conditions

Carcinoma, Hepatocellular

Treatments

Device: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01078415

ONC-205

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.