A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

Exclusion Criteria

• •1. Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy.
• •2. Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade.
• •3. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000.
• •4. Subjects with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.
• •5. Subjects with history of epilepsy or other neurological disease.
• •6. Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator.
• •7. Subjects with Stage 3, 4, or 5 chronic kidney disease.
• •8. Subjects receiving IRE for margin accentuation.
• •9. Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression.
• •10. Participation in another interventional trial for pancreatic cancer.
• •11. Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months.