CompletedNot Applicable

ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial

Czechia, Germany, Israel54 participantsStarted 2009-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

engulfment of the tumor by the ice-ball as seen under ultrasound imaging

Timeframe: during the procedure

Trial details

NCT IDNCT00910312

SponsorIceCure Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Fibroadenoma trials