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High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

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: NCT01422629
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Theraclion

Tracking Information
First Submitted Date  ICMJE August 18, 2011
First Posted Date  ICMJE August 24, 2011
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma [ Time Frame: 6 months after HIFU treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
HIFU induced tissue necrosis assessed by histology of excised gland [ Time Frame: two months after HIFU treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • Volume reduction of the fibroadenoma [ Time Frame: 12 months after HIFU treatment ]
    reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery
  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. [ Time Frame: at treatment ]
  • Percentage of patients with Adverse events [ Time Frame: at 12 months follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2011)
  • - Volume reduction of the fibroadenoma [ Time Frame: two months after HIFU treatment ]
    - Volume reduction of the fibroadenoma measured by ultrasonography 2 months after HIFU treatment, just before surgery
  • - Pain score during the HIFU treatment evaluated by the Visual Analog Scale. [ Time Frame: at treatment ]
  • Percentage of patients with Adverse events [ Time Frame: at 6 months follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma
Official Title  ICMJE High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma: a Feasibility Study. A Multicentric, Open, Uncontrolled Study
Brief Summary

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

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: Basic Science
Condition  ICMJE Breast Fibroadenoma
Intervention  ICMJE Device: Ultrasonic ablation device
High Intensity focused ultrasound treatment
Other Name: TH-One
Study Arms  ICMJE Experimental: High Intensity Focused Ultrasound (HIFU)
Intervention: Device: Ultrasonic ablation device
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2011)
20
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
  • Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)

Exclusion Criteria:

  • Patient pregnant or lactating
  • Microcalcifications within the lesion at the mammogram.
  • History of breast cancer or history of laser or radiation therapy to the target breast
  • Breast implant in the target breast.
  • 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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01422629
Other Study ID Numbers  ICMJE HIFU/F/FA/Dec2010
Has Data Monitoring Committee Yes
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: Loïc BOULANGER, MD Hôpital Jeanne de Flandre, CHU de Lille - FRANCE
PRS Account Theraclion
Verification Date April 2014

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