Open Actively Recruiting
Ablation Confirmation Study
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
- A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 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 greater than or equal to 22 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification
- 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).
- Active bacterial infection or fungal infection on the day of the ablation.
- Patients with implantable pacemakers or other electronic implants.
- Platelet count less than 50,000/mm cubed.
- Patients with uncorrectable coagulopathy at the time of ablation.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of great or equal to 4.
- Use of hydrodissection.
- Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure.
- INR greater than 1.8.
- 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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
- UCLA Westwood