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