Last updated on June 2018

Treatment of Breast Fibroadenoma With FastScan HIFU

Brief description of study

This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

Detailed Study Description

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

Clinical Study Identifier: NCT02488655

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Roussanka Kovatcheva, Prof.

University Hospital of Endocrinology USBALE
Sofia, Bulgaria
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