Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU-FA-001)
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|ClinicalTrials.gov Identifier: NCT02078011|
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : May 7, 2018
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).
This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Fibroadenoma||Device: High Intensity Focused Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 29, 2016|
|Actual Study Completion Date :||October 1, 2017|
Experimental: HIFU treatment
The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die
Device: High Intensity Focused Ultrasound
The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).
Other Name: Echopulse
- Change in volume of fibroadenoma [ Time Frame: baseline, 3, 6, and 12 months ]Fibroadenoma volume with be measured by ultrasound.
- Size of fibroadenoma [ Time Frame: baseline, 3, 6, and 12 months ]Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
- Patient reported outcomes [ Time Frame: up to 12 months ]Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session
- Incidence of adverse events [ Time Frame: up to 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078011
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||David Brenin, MD||University of Virginia|