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

This study is currently recruiting participants.
Verified December 2013 by Theraclion
Information provided by (Responsible Party):
Theraclion Identifier:
First received: December 10, 2013
Last updated: December 18, 2013
Last verified: December 2013

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device

Condition Intervention Phase
Breast Fibroadenoma
Device: Echopulse
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Further study details as provided by Theraclion:

Primary Outcome Measures:
  • FA volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: December 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients 18 years or older with at least one diagnosed breast fibroadenoma.
  • Diagnosis of fibroadenoma must be based on:

    • clinical examination,
    • women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram,
    • histological confirmation of fibroadenoma of the breast.
  • Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm.
  • Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment.
  • Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures.
  • Patient must give written informed consent (personally signed and dated) before completing any study-related procedure.

Exclusion Criteria:

  • Patient who is pregnant or breast-feeding.
  • Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion.
  • Patient with implant on the treated breast.
  • Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU.
  • Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
  • Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
  Contacts and Locations
Please refer to this study by its identifier: NCT02011919

Contact: Markus Hahn, PD Med +49 7071 2982211

Tubingen University Hospital Recruiting
Tubingen, Germany
Contact: Markus Hahn, PD Dr.         
Principal Investigator: Markus Hahn, PD Dr.         
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Theraclion Identifier: NCT02011919     History of Changes
Other Study ID Numbers: HIFU / TU / FA
Study First Received: December 10, 2013
Last Updated: December 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial processed this record on April 21, 2014