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Brief Title: Treatment of Breast Fibroadenoma Targeted Tissue With HIFU
Official Title: Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
Study ID: NCT03044054
Brief Summary: This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Bellevue Hospital Center, New York, New York, United States
New York Columbia University Medical Center, New York, New York, United States
Montefiore-Einstein Center for Cancer Care, New York, New York, United States
University of Virginia Health system, Charlottesville, Virginia, United States
Name: Michel NUTA, MD
Affiliation: Theraclion
Role: STUDY_DIRECTOR