ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Fibroadenoma Clinical Trial

— ICE-CRYSTAL  

Official title:

Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910312
• Other study ID #: AM-03
• Secondary ID: version 5.0
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: January 2013

Study information

• Verified date: April 2016
• Source: IceCure Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibroadenoma

Intervention

Device:
• Ice-Sense
Ice-Sense Cryoprobe

Locations

Country	Name	City	State
Czechia	Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague	Prague
Germany	Department of Obstetrics and Gynecology, University Hospital of Heidelberg	Heidelberg
Germany	Department of Obstetrics and Gynecology, University Hospital of Tuebingen	Tübingen
Israel	Assuta medical centers	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
IceCure Medical Ltd.

Countries where clinical trial is conducted

Czechia,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	engulfment of the tumor by the ice-ball as seen under ultrasound imaging		during the procedure
Secondary	any device related adverse events or complications that may occur		one year