Echopulse for treatment of breast fibroadenomas in women
Treatment of Breast Fibroadenoma targeted tissue with High Intensity Focused Ultrasound (HIFU): A Pivotal Multi Center Prospective Study
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).Several symptoms could be associated to the presence of fibroadenoma. Some patients may experience pain, anxiety and discomfort permanently or during their menstrual cycle. A biopsy (using a needle to take a small piece of the lump and exam the cells) is necessary in order to be sure that the lump is benign.
Are you Eligible? (Inclusion Criteria)
Female Patients Only