Breast Fibroadenoma Clinical Trial
Official title:
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility 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 that are made of glandular and fibrous breast tissue. 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).
This is a study about the Echopulse device, a computer driven system which uses ultrasound to
guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the
breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes
the cells to die and allows the possibility to treat the fibroadenoma without the need for
surgery.
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