American Breast Laser Ablation Therapy Evaluation (ABLATE)

Novian Health

Status: Completed

Conditions: Benign Breast Conditions; Breast Fibroadenomas

Study type: Observational

Funder types: Industry

Identifiers

NCT00807924

BR001

Details and patient eligibility

About

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.

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.

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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