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