Inclusion Criteria:

- One breast fibroadenoma with diagnosis based on:

- Clinical examination

- Ultrasound image

- For women older than 35 years: mammogram with BI-RADS score < 3

- Histologic confirmation by two independent readers

- Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by
ultrasound)

Exclusion Criteria:

- Patient pregnant or lactating

- Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.

- History of breast cancer or history of laser or radiation therapy to the target
breast

- Breast implants

- Breast cyst

- Fibroadenoma not clearly visible on the ultrasound images (in B mode)

- Patient participating in other trials using drugs or devices