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

This study is currently recruiting participants.
Verified December 2013 by Theraclion
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT02011919
First received: December 10, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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
Echopulse HIFU
Device: Echopulse
HIFU Under ultrasound guidance

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02011919

Contacts
Contact: Markus Hahn, PD Med +49 7071 2982211 Markus.Hahn@med.uni-tuebingen.de

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

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov 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:
Fibroadenoma
Neoplasms, Fibroepithelial
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on April 21, 2014