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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
engulfment of the tumor by the ice-ball as seen under ultrasound imaging