American Breast Laser Ablation Therapy Evaluation (ABLATE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
Benign Breast Conditions; Breast Fibroadenomas
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.
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.
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 Novilase™
Patient is pregnant or lactating
Hypercellularity suggestive of phyllodes
Equivocal pathology report (e.g., discordance between radiographic and microscopic results)