Clinical Trial: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Brief Summary: Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.
Detailed Summary:
Sponsor: Theraclion
Current Primary Outcome: Reduction of breast fibroadenoma volume at ultrasonography [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
- Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up [ Time Frame: 1 year ]
- Lack of palpable lesion [ Time Frame: 2 years ]
- Pain free if pain at baseline (pain related to the fibroadenoma) [ Time Frame: 1 year ]
- Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session [ Time Frame: 1 year ]
- Pain during the HIFU session using a Visual Analog Pain Scale [ Time Frame: 0 month ]
- Histological outcome through core needle biopsy after 12 month [ Time Frame: 1 year ]
- Quality and ease of use of breast immobilization [ Time Frame: 1 year ]
Information By: Theraclion
Dates:
Date Received: July 1, 2015
Date Started: October 2013
Date Completion: March 2018
Last Updated: April 26, 2017
Last Verified: April 2017