ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Not Applicable
Completed
- Conditions
- Fibroadenoma
- Interventions
- Device: Ice-Sense
- Registration Number
- NCT00910312
- Lead Sponsor
- IceCure Medical Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Breast Fibroadenoma Ice-Sense -
- Primary Outcome Measures
Name Time Method engulfment of the tumor by the ice-ball as seen under ultrasound imaging during the procedure
- Secondary Outcome Measures
Name Time Method any device related adverse events or complications that may occur one year
Trial Locations
- Locations (4)
Assuta medical centers
🇮🇱Haifa, Israel
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
🇩🇪Heidelberg, Germany
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
🇩🇪Tübingen, Germany
Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
🇨🇿Prague, Czechia