ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial (ICE-CRYSTAL)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.