Clinical Trials

Inclusion Criteria

• A patient with at least one soft-tissue liver lesion ≤ 5 cm undergoing MWA using the NEUWAVE Microwave Ablation System. Note: A patient cannot have more than three lesions ablated during the procedure.
• Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure.
• Written informed consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor.
• Patients ≥ 22 years old.
• Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG]).
• Class A or B functional hepatic reserve based on the Child-Pugh score.
• Lesion must be visualized by non-contrast enhanced CT scan -or- the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR).

Exclusion Criteria:

• Active bacterial infection or fungal infection on the day of the ablation.
• Patients with implantable pacemakers or other electronic implants.
• Platelet count < 50,000/mm^3  
• Patients with uncorrectable coagulopathy at the time of ablation.
• Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
• Physical or psychological condition which would impair study participation.
• ASA (American Society of Anesthesiologists) score of ≥ 4.
• Use of hydrodissection.
• Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, within 30 days prior to the study ablation procedure.
• Systemic Chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
• INR > 1.85.
• Patient has participated in an investigational clinical study within 30 days of the screening visit for this study.
• Patient judged unsuitable for study participation by the performing physician for any other reason.

Eligibility last updated 9/7/21. Questions regarding updates should be directed to the study team contact.