ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01331954
Recruitment Status : Active, not recruiting
First Posted : April 8, 2011
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Theraclion

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

Condition or disease Intervention/treatment Phase
Breast Fibroadenoma Device: Ultrasonic ablation device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Study Start Date : March 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: HIFU Device: Ultrasonic ablation device
One or two HIFU procedures
Other Name: TH-One



Primary Outcome Measures :
  1. Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331954


Locations
Bulgaria
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Roussanka Kovatcheva, M University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01331954     History of Changes
Other Study ID Numbers: HIFU/BG/FA/Jan2011
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial