This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device

Inclusion Criteria:

• Female patients 18 years or older with at least one diagnosed breast fibroadenoma.

• Diagnosis of fibroadenoma must be based on:

  • clinical examination,
  • women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram,
  • histological confirmation of fibroadenoma of the breast.

• Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.

• Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.

• Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.

• Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.

Exclusion Criteria:

• Patient who is pregnant or breast-feeding.
• Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
• Patient with implant on the treated breast.
• Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
• Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
• Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.