Breast Cancer Clinical Trial
American Breast Laser Ablation Therapy Evaluation
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
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There is 1 Location for this study
New York New York, 10032, United States More Info
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