NCT02488655

Treatment of Breast Fibroadenoma With FastScan HIFU

Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Theraclion · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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 85-90°C.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.

Conditions

• Breast Fibroadenoma

Interventions

Type	Name	Description
DEVICE	Echopulse	HIFU Under ultrasound guidance

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-07-02
• Last updated: 2021-10-19

Locations

1 site across 1 country: Bulgaria