NeuWave Microwave Ablation HCC China Study

Launched by ETHICON, INC. · Dec 20, 2018

Keywords

ClinConnect Summary

Patients who have a single HCC tumor up to 5 cm or a maximum of 3 HCC tumors of up to 3 cm per tumor will receive the same procedure: microwave ablation using only the NeuWave Certus Microwave Ablation System. Patients in this study will come to their study site for the ablation procedure. After the ablation procedure, the patient will be observed, which in most cases is expected to be 2 to 3 hours, and afterwards may return home. If the Study Doctor decides it is warranted for patient safety, the patient will remain in the hospital longer.

A minimum of one MRI of the liver must be taken a...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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.