High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

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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 conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

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Detailed Description

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Conditions

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Breast Fibroadenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High Intensity Focused Ultrasound (HIFU)

Group Type EXPERIMENTAL

Ultrasonic ablation device

Intervention Type DEVICE

High Intensity focused ultrasound treatment

Interventions

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Ultrasonic ablation device

High Intensity focused ultrasound treatment

Intervention Type DEVICE

Other Intervention Names

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TH-One

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No