Ablation Confirmation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin. All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Official Title
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A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion

Conditions
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Cancer of the Liver, Liver Cancer, Neoplasms, Liver

Intervention / Treatment
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* Device: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microwave Ablation<br>NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist. | Device: Microwave Ablation<br>* NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients where probe repositioning is suggested | The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement. | Day of ablation (day 0) | 
| Percentage of patients where re-ablation is suggested | The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins. | Day of ablation (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse Events | Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion. | 6 weeks post-ablation | 
| Technical Success | Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure. | Day of ablation (day 0) | 
| Technique Efficacy | Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging. | 6 weeks post-ablation | 
| Hospital Resource Utilization #1: Time to perform the ablation procedure, | The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation | Day of ablation (day 0) | 
| Hospital Resource Utilization #2: Length of hospital stay (if applicable) | The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Length of hospital stay (if applicable) | 6 weeks post-ablation |