Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

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 complete tumor ablation rate is greater than 87.85%.