This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.
Biologic female
50 years of age and older
Infiltrating ductal carcinoma
ER/PR+Her2neu-
Pregnant or breastfeeding
Neoadjuvant chemotherapy
Cardiac arrhythmia
Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device