American Breast Laser Ablation Therapy Evaluation (ABLATE)

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.

Patients undergoing Novilase for the treatment of benign breast conditions at Novian Health affiliated breast centers.

• Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. Am J Surg. 2002 Oct;184(4):359-63.
• Dowlatshahi K, Dieschbourg JJ, Bloom KJ. Laser therapy of breast cancer with 3-year follow-up. Breast J. 2004 May-Jun;10(3):240-3.
• Dowlatshahi K, Wadhwani S, Alvarado R, Valadez C, Dieschbourg J. Interstitial Laser Therapy of Breast Fibroadenomas With 6 and 8 Year Follow-Up. Breast J. 2009 Oct 12; [Epub ahead of print]

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 Novilase™

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