Clinical Trial: Treatment of Breast Fibroadenoma With FastScan HIFU

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Breast Fibroadenoma With FastScan High Intensity Focused Ultrasound (HIFU)

Brief Summary: This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

Detailed Summary:

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.


Sponsor: Theraclion

Current Primary Outcome:

  • Number of participants with adverse events [ Time Frame: 1 day post treatment ]
  • Number of participants with adverse events [ Time Frame: 3 days post treatment ]
  • Number of participants with adverse events [ Time Frame: 7 days post treatment ]
  • Change from Baseline volume of the fibroadenoma at 6 months [ Time Frame: 6 months post treament ]
  • Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day [ Time Frame: 1 day post treatment ]
  • Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days [ Time Frame: 3 days post treatment ]
  • Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days [ Time Frame: 7 days post treatment ]
  • Patient satisfaction questionnaire [ Time Frame: 6 months post treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with absence of palpable lesion [ Time Frame: 3 months post treatment ]
  • Number of participants with absence of palpable lesion [ Time Frame: 6 months post treatment ]
  • Patient Cosmetic evaluation as measured by questionnaire [ Time Frame: 6 months post treatment ]
  • Investigator rated evaluation of the device [ Time Frame: Post treatment Day 0 ]
  • Change from Baseline gland vascularization at 3 months [ Time Frame: 3 months post treatment ]
  • Change from Baseline gland vascularization at 6 months [ Time Frame: 6 months post treatment ]


Original Secondary Outcome: Same as current

Information By: Theraclion

Dates:
Date Received: June 24, 2015
Date Started: June 2015
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: April 2017