Novian Health Inc.
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be invited to participate. Subjects will receive a screening MRI and if eligible will then have laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure. This study will be deemed successful if the lower limit of a 95% confidence interval for the proportion of patients who have complete tumor ablation with one Novilase laser ablation procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically, Novilase will have demonstrated success if the compl…
Inclusion Criteria: * Females, aged 18 years and older * Able to give written informed consent herself * Definitive pathologic diagnosis by needle core biopsy * Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic * No more than 10 mm of calcifications confined to the tumor on imaging * Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance…
Image-guided, percutaneous laser ablation of breast tumors