Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : Unknown
Verified May 2018 by Theraclion.
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2011
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Theraclion

Tracking Information
First Submitted Date  ICMJE April 7, 2011
First Posted Date  ICMJE April 8, 2011
Last Update Posted Date May 29, 2018
Actual Study Start Date  ICMJE March 2011
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Official Title  ICMJE Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Brief Summary Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Fibroadenoma
Intervention  ICMJE Device: Ultrasonic ablation device
One or two HIFU procedures
Other Name: TH-One
Study Arms  ICMJE Experimental: HIFU
Intervention: Device: Ultrasonic ablation device
Publications * Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 5, 2012)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2011)
10
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01331954
Other Study ID Numbers  ICMJE HIFU/BG/FA/Jan2011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theraclion
Study Sponsor  ICMJE Theraclion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roussanka Kovatcheva, M University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
PRS Account Theraclion
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP