NeuWave Microwave Ablation HCC China Study

Prior treatment

• Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure.
• Patient with implantable pacemakers or other electronic implants.
• Planned/ scheduled liver surgery.
• Scheduled concurrent procedure other than MW ablation in the liver.
• Participation in any other interventional clinical study within 1 month before screening and concurrently during the study.

Other illness

• Active bacterial or fungal infections which are clinically significantly.
• Patient with renal failure and on renal dialysis.
• Physical or psychological condition which would impair study participation.

Lab values

• Platelet count ≤ 50 × 109/L.
• Patients with uncorrectable coagulopathy at time of screening based on investigator judgement. Severe blood coagulation dysfunction (bleeding tendency, prothrombin time \[PT\] was greater than normal control for 3\~5 seconds, platelet count \[PLT\] was less than 50x109/L, and the international normalized ratio \[INR\] was greater than 1.5).

Other

• ASA score ≥ 4.
• Pregnant or breast feeding.
• The patient is judged unsuitable for study participation by the investigator for any other reason.

• Diagnosed primary or recurrent HCC determined in accordance with the institution's SOC procedure, a single tumor size up to 5 cm or a maximum of 3 tumors up to 3 cm per tumor. Tumor size must be measured with at least 2-dimensional (2D) imaging.
• Scheduled for microwave ablation of the liver.
• Performance status 0-2 (Eastern Cooperative Oncology Group classification).
• Functional hepatic reserve based on the Child-Pugh score (Class A or B).
• Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule.
• At least 18 years of age.