Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Theraclion

Status

Completed

Conditions

Breast Fibroadenoma

Treatments

Device: Echopulse

Study type

Interventional

Funder types

Industry

Identifiers

NCT02011919

HIFU / TU / FA

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.