Trials / Completed
CompletedNCT03044054
Treatment of Breast Fibroadenoma Targeted Tissue With HIFU
Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Theraclion · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ECHOPULSE | HIFU Under ultrasound guidance |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2025-11-01
- Completion
- 2025-11-01
- First posted
- 2017-02-06
- Last updated
- 2026-03-04
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03044054. Inclusion in this directory is not an endorsement.