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

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01331954

Enrollment

Registered

2011-04-08

Start date

2011-03-31

Completion date

2024-09-30

Last updated

2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Fibroadenoma

Brief summary

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

Interventions

DEVICEUltrasonic ablation device

One or two HIFU procedures

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction of breast fibroadenoma volume at ultrasonography	12 months

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026