Clinical Trial: Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

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

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

Brief Summary: This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.

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.
Sponsor: Theraclion

Current Primary Outcome:

  • Pain level assessment [ Time Frame: 12 Months ]
    visual analog scale
  • Anxiety level assessment [ Time Frame: 12 Months ]
    visual analog scale
  • Volume assessment [ Time Frame: 12 Months ]
    Ultrasound measurement


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The short (6-item) version of the State-Trait Anxiety Inventory (STAI) [ Time Frame: Day 0, Day 2/3, Day 7, 6 months, 12 months ]
  • Palpability of the breast fibroadenoma [ Time Frame: Day 0, Day 2/3, Day 7, 6 months, 12 months ]
    Physician clinical examination
  • Freedom from additional procedures for fibroadenoma of the breast [ Time Frame: Day 0, Day 2/3, Day 7, 6 months, 12 months ]
    Physician assessment concerning the need of additional procedures
  • Patient satisfaction [ Time Frame: Month 6 and Months 12 ]
    Self assessment satisfaction questionnaire
  • Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial. [ Time Frame: Day 0, Day 2/3, Day 7, 6 months, 12 months ]
    Assessment and capture of adverse events


Original Secondary Outcome: Same as current

Information By: Theraclion

Dates:
Date Received: January 17, 2017
Date Started: January 2017
Date Completion: January 2020
Last Updated: April 26, 2017
Last Verified: April 2017