This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatment ablation with the nanoknife low energy direct current (ledc) system
Sponsor Angiodynamics, Inc.
Start date February 2010
End date October 2011
Trial size 25 participants
Trial identifier NCT01078415, ONC-205


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
time frame: 30 days (+/- 3 days) post treatment

Secondary Outcomes

Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
time frame: Immediately post treatment to 2 years post treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)
Principal investigator Riccardo Lencioni, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Angiodynamics, Inc..