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