Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms

Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: Phase I and Phase II Clinical Trial

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Rectal Neoplasms.

By enrolling patients with unresectable Rectal 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 Rectal Neoplasms.

Inclusion Criteria:

• Rectal 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.