ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma

The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.

Inclusion Criteria:

• Patient is above 18 years old.
• Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
• Patient's fibroadenoma can be visualized with ultrasound.
• Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
• Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
• The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization.

Exclusion Criteria:

• Patients with history of breast cancer.
• Women with known pregnancy.
• Patients with superficial fibroadenoma very close to the skin.
• Patient has undergone major surgery within the previous 12 weeks.
• Patients with any terminal illness, or with a life expectancy <2 year.
• Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
• Patient participating in other trials using drugs or devices.