ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Not Applicable

Completed

• Conditions: Fibroadenoma

• 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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-04
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

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

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)

Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague; 🇨🇿 Prague, Czechia

Department of Obstetrics and Gynecology, University Hospital of Heidelberg; 🇩🇪 Heidelberg, Germany

Department of Obstetrics and Gynecology, University Hospital of Tuebingen; 🇩🇪 Tübingen, Germany

Assuta medical centers; 🇮🇱 Haifa, Israel