Status:
COMPLETED
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Lead Sponsor:
IceCure Medical Ltd.
Conditions:
Fibroadenoma
Eligibility:
FEMALE
18+ years
Phase:
NA
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 fibr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00910312
Start Date
April 1 2009
End Date
January 1 2013
Last Update
August 17 2022
Active Locations (4)
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1
Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
Prague, Czechia, 128 00
2
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
Heidelberg, Germany
3
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
Tübingen, Germany
4
Assuta medical centers
Haifa, Israel