Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound

NCT ID: NCT02078011

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-10-01

Brief Summary

The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).

This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.

Conditions

Breast Fibroadenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU treatment

The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die

Group Type: EXPERIMENTAL

High Intensity Focused Ultrasound

Intervention Type: DEVICE

The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).

Interventions

High Intensity Focused Ultrasound

The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).

Intervention Type: DEVICE

Other Intervention Names

Echopulse

Eligibility Criteria

Inclusion Criteria

• Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
• Fibroadenoma is palpable
• Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
• Fibroadenoma volume is between 2 cc and 10 cc
• Patient must give written informed consent (personally signed and dated) before completing any study-related procedure

Exclusion Criteria

• Patient is pregnant or nursing
• Patient with breast implants in the target breast
• Patient with a breast cyst within the fibroadenoma to be treated
• Patient participating in another clinical trial involving an investigational drug, device or biologic

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theraclion SAS, Paris, France

UNKNOWN

Sponsor Role: collaborator

David R. Brenin, MD

OTHER

Sponsor Role: lead

Responsible Party

David R. Brenin, MD

Associate Professor, Department of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Brenin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

17277

Identifier Type: -

Identifier Source: org_study_id