Clinical Trial: Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
Brief Summary: The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..
Detailed Summary: Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
Sponsor: Theraclion
Current Primary Outcome: Changes in size of fibroadenomata as recorded on ultrasound imaging [ Time Frame: Month 1, Month 3, Month 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse Events [ Time Frame: Month 1, Month 3, Month 12 ]
- Patient recorded outcomes measures [ Time Frame: Month 1, Month 3, Month 12 ]Patient questionnaires and VAS scales
- Mean treatment time [ Time Frame: Treatment visit date ]
- Cost-effectiveness [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Theraclion
Dates:
Date Received: February 5, 2014
Date Started: January 2014
Date Completion: December 2017
Last Updated: April 20, 2016
Last Verified: April 2016