Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms
Irreversible Electroporation(IRE) For Unresectable Extremities Neoplasms
The purpose of this study is to evaluate the safety and efficacy of irreversible
 electroporation (IRE) for unresectable Extremities Neoplasms.
By enrolling patients with unresectable Extremites Neoplasms adapted to enrolled criteria,
 this study will document for the first time the safety and the short and long term efficacy
 of percutaneous IRE for unresectable Extremities Neoplasms.
Inclusion Criteria:

 -  Extremities Neoplasms diagnosed by positive biopsy or non-invasive criteria,

 -  Not suitable for surgical resection,

 -  Eastern Cooperative Oncology Group (ECOG) score of 0-1,

 -  A prothrombin time ratio > 50%,

 -  Platelet count > 80x10^9/L,

 -  Ability of patient to stop anticoagulant and anti-platelet therapy for seven days
 prior to and seven days post NanoKnife procedure,

 -  Able to comprehend and willing to sign the written informed consent form (ICF),

 -  Have a life expectancy of at least 3 months.

 Exclusion Criteria:

 -  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.