Clinical Trial: ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
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 Summary:
Sponsor: IceCure Medical Ltd.
Current Primary Outcome: engulfment of the tumor by the ice-ball as seen under ultrasound imaging [ Time Frame: during the procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome: any device related adverse events or complications that may occur [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: IceCure Medical Ltd.
Dates:
Date Received: May 28, 2009
Date Started: April 2009
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016