NeuWave HCC China Study

Inclusion Criteria:

1. 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.
2. Scheduled for microwave ablation of the liver.
3. Performance status 0-2 (Eastern Cooperative Oncology Group classification).
4. Functional hepatic reserve based on the Child-Pugh score (Class A or B).
5. Give voluntary, written informed consent to participate in this study and willing to comply with study-related evaluation and procedure schedule.
6. At least 18 years of age.

Exclusion Criteria:

1. ASA score ≥ 4.
2. Active bacterial or fungal infections which are clinically significantly.
3. Chemotherapy or radiation therapy for HCC performed within 30 days prior to the study procedure.
4. Patient with implantable pacemakers or other electronic implants.
5. Planned/ scheduled liver surgery.
6. Platelet count ≤ 50 × 109/L.
7. 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).
8. Patient with renal failure and on renal dialysis.
9. Scheduled concurrent procedure other than MW ablation in the liver.
10. Pregnant or breast feeding.
11. Physical or psychological condition which would impair study participation.
12. Participation in any other interventional clinical study within 1 month before screening and concurrently during the study.
13. The patient is judged unsuitable for study participation by the investigator for any other reason.