The purpose of this patient tracking program is to monitor long term safety and effectiveness of the Novilase™ 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.
Study Type
OBSERVATIONAL
Enrollment
108
Columbia University Medical Center - Department of Surgery
New York, New York, United States
To monitor and measure long term safety and effectiveness Novilase
Time frame: ongoing
To help refine, improve and/or validate breast tumor best practices and standard of care
Time frame: ongoing
To help establish uniform and standardized imaging, pathological assessment and ablation timing protocols
Time frame: ongoing
To support the medical and patient communities through transparency--by contributing and publishing relevant, useful and meaningful data to support the development and design of future research
Time frame: ongoing
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