The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilaseâ„¢ device and method in real world application.
ABLATE is a prospective, observational multi-center tracking database which will evaluate clinical outcomes from patients undergoing Novilase for benign breast conditions (i.e. fibroadenomas, papillomas, etc). Data captured will assess the potential advantages and disadvantages of the procedure as compared with lumpectomy. Tumor characteristics, equipment used, complications, patient satisfaction and cosmesis ratings will also be tracked.
Diagnosis confirmed by needle core biopsy Tumors detected either by physical exam or imaging Tumors do not exceed 2 cm in diameter and measure at least 0.5 cm away from the skin and chest wall Single, multiple and/or bilateral tumors Patient has given consent prior to being treated with Novilaseâ„¢
Exclusion Criteria:
Patient is pregnant or lactating Hypercellularity suggestive of phyllodes Atypia Equivocal pathology report (e.g., discordance between radiographic and microscopic results) Fibroadenomas with stromal solidarity
