This trial is active, not recruiting.

Condition breast fibroadenoma
Treatment ultrasonic ablation device
Sponsor Theraclion
Start date March 2011
End date October 2016
Trial size 20 participants
Trial identifier NCT01331954, HIFU/BG/FA/Jan2011


Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
ultrasonic ablation device TH-One
One or two HIFU procedures

Primary Outcomes

Reduction of breast fibroadenoma volume at ultrasonography
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - One breast fibroadenoma with diagnosis based on: - Clinical examination - Ultrasound image - For women older than 35 years: mammogram with BI-RADS score < 3 - Histologic confirmation by two independent readers - Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound) Exclusion Criteria: - Patient pregnant or lactating - Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion. - History of breast cancer or history of laser or radiation therapy to the target breast - Breast implants - Breast cyst - Fibroadenoma not clearly visible on the ultrasound images (in B mode) - Patient participating in other trials using drugs or devices

Additional Information

Official title Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Principal investigator Roussanka Kovatcheva, M
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Theraclion.