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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Loma Linda University Medical Center
Loma Linda, California, United States
UCLA
Los Angeles, California, United States
Olives View - UCLA Medical Center
Sylmar, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Percentage of Lesions Where Probe Repositioning is Suggested
Time frame: Day 0
Percentage of Lesions Where Re-ablation is Suggested
Time frame: Day 0
Technical Success
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)
Time frame: Day 0
Technique Efficacy
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) as assessed by imaging at 6 weeks
Time frame: 6 weeks
Hospital Resource Utilization
How many days patients remain in the hospital after the ablation procedure
Time frame: 6 weeks
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MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States