Study to Evaluate VORTX Rx (Theresa)

Inclusion Criteria

• Written informed consent before any study procedure is performed.
• Subjects of both sexes aged 18 years or older.
• Patients diagnosed with liver cancer, including HCC or liver metastases from breast, pancreas and/or colorectal cancers. If biopsy is required, there will be a minimum of 2-week period after biopsy and before the ablation.
• HCC patients must meet the United Network for Organ Sharing and Organ Procurement and Transplantation Network (UNOS-OPTN) class 5 criteria for HCC (52).
• Liver metastases patients must meet minimum criteria of liver biopsy and/or tissue diagnosis of primary tumor or metastatic tumor with new or growing liver tumors radiologically consistent with metastases.
• Patients with liver cancer not candidates for surgical resection and/or not suitable for other locoregional treatments or patients who have not responded to or relapsed from conventional therapies.
• Previous treatment with chemotherapy and/or radiotherapy is permitted provided that these treatments have been discontinued more than 2 weeks before the ablation and whenever patients have recovered from any related toxicity (53).
• Previous treatment with immunotherapies is permitted provided that these therapies have been discontinued at least 4 weeks before the ablation and whenever patients have recovered from any related toxicity.
• Previous ablation/surgery on other tumors different from those that will be targeted with the VORTX Rx® is allowed whenever a minimum of 2 weeks has elapsed since the prior procedure(s).
• Tumor to be targeted for ablation will be clearly separated from other tumors or other critical areas (i.e. located in different segments of the liver) and located in segment 2, 3, 4, 5 or 6.
• Largest diameter of targeted tumor ≤3 cm.
• Tumor that will be targeted at a depth 1.0 x 109/L and platelet > 50 x 109/L).
• An INR 50 x 109/L within the last 7 days prior to the ablation.

Exclusion Criteria

• Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form.
• Pregnant or nursing (lactating) women; women of childbearing potential and sexually active that are unwilling to use adequate contraception (such as oral contraceptives, intrauterine contraceptive device or barrier method with spermicide or surgical sterilization).
• Targeted tumor not clearly separated (i.e. located in the same liver segment as another tumor).
• Targeted tumor located in liver segments 1, 7 or 8.
• Targeted tumor >3 cm.
• Tumor that will be targeted >10 cm from the skin surface.
• Tumor not clearly visible with diagnostic ultrasound and MRI.
• Liver function score of Child-Pugh C.
• Liver volume reserve 30.
• Parkinson's disease.
• History of bleeding disorders (e.g. von Willebrand disease) or patients suspected to have a bleeding disorder.
• Not able to temporarily discontinue warfarin, clopidogrel or any other long-acting anticoagulants at least two weeks before the procedure.
• Initiation of any anticancer treatment during the screening period and during the follow-up study visits.
• Life expectancy to be less than 6 months.
• Unable or unwilling to complete all required screening and/or follow-up assessments.
• Patients under ongoing treatment with an investigational medication or medical device that conflicts with the study device.
• Patients for whom the investigator considers that the ablation is not in the patient's best interest.
• Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
• Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
• Patients with known sensitivity to iodine.