Fibroadenoma
Conditions
Brief summary
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.
Interventions
DEVICEIce-Sense
Ice-Sense Cryoprobe
Sponsors
IceCure Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| engulfment of the tumor by the ice-ball as seen under ultrasound imaging | during the procedure |
Secondary
| Measure | Time frame |
|---|---|
| any device related adverse events or complications that may occur | one year |
Countries
Czechia, Germany, Israel
Outcome results
None listed