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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Angiodynamics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01078415
First received: February 26, 2010
Last updated: September 26, 2011
Last verified: September 2011

February 26, 2010
September 26, 2011
February 2010
October 2011   (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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01078415 on ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
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
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
October 2013
October 2011   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Spain
 
NCT01078415
ONC-205
No
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.
September 2011

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