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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

NCT03044054

Breast Fibroadenoma

RECRUITING NA

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

NCT02011919

Breast Fibroadenoma

COMPLETED NA

Treatment of Benign Thyroid Nodules With FastScan HIFU

NCT02491502

Benign Thyroid Nodules

COMPLETED NA

Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.

NCT02246504

Non-malignant Thyroid Nodule

COMPLETED NA

A Prospective Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Benign Thyroid Nodules

NCT02658552

Benign Thyroid Nodules

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Fibroadenoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIFU

Group Type EXPERIMENTAL

Ultrasonic ablation device

Intervention Type DEVICE

One or two HIFU procedures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasonic ablation device

One or two HIFU procedures

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TH-One

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No