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