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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078415
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Angiodynamics, Inc.

February 26, 2010
March 2, 2010
November 8, 2016
February 2010
January 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01078415 on Archive Site
Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. [ Time Frame: Immediately post treatment to 2 years post treatment ]
Same as current
Not Provided
Not Provided
Pilot Study of Irreversible Electroporation (IRE) to Treat Early-Stage Primary Liver Cancer (HCC)
A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)
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).
Not Provided
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Device: Ablation with the NanoKnife Low Energy Direct Current (LEDC) System
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Other Names:
  • System also known as:
  • * Low Energy Direct Current (LEDC) System
  • * HVP01 Electroporation System
  • * NanoKnife LEDC System
  • * NanoKnife IRE System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Spain
Not Provided
Not Provided
Angiodynamics, Inc.
Angiodynamics, Inc.
Not Provided
Principal Investigator: Riccardo Lencioni, MD University of Pisa School of Medicine
Principal Investigator: Jordi Bruix, MD Barcelona Clinic Liver Cancer (BCLC) Group of the University of Barcelona
Angiodynamics, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP