Status:
COMPLETED
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma
Lead Sponsor:
Theraclion
Conditions:
Breast Fibroadenoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU). This study will be conduct...
Eligibility Criteria
Inclusion
- Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
- Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)
Exclusion
- Patient pregnant or lactating
- Microcalcifications within the lesion at the mammogram.
- History of breast cancer or history of laser or radiation therapy to the target breast
- Breast implant in the target breast.
- Fibroadenoma not clearly visible on the ultrasound images (in B mode)
- Patient participating in other trials using drugs or devices
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01422629
Start Date
October 1 2011
End Date
February 1 2014
Last Update
April 9 2014
Active Locations (2)
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1
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret
Lille, France, 59000
2
Hôpital Américain de Paris
Neuilly-sur-Seine, France, 92200