Clinical trial · Interventional
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU
High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
NCT02139683CI-TRIAL-00033123completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Fibroadenoma | Breast Fibroadenoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIFU treatment
- description
- HIFU treatment in patient diagnosed with fibroadenoma
- interventionNames
- Device: HIFU treatment
Primary outcomes (1)
- measure
- Changes in size of fibroadenomata as recorded on ultrasound imaging
- timeFrame
- Month 1, Month 3, Month 12
Secondary outcomes (4)
- measure
- Adverse Events
- timeFrame
- Month 1, Month 3, Month 12
- measure
- Patient recorded outcomes measures
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years of age * Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients \<25 and ultrasound plus core-biopsy in patients \>25 (Graded B2 or less) * Visible on ultrasound (Graded U2/U3) * Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT). Exclusion Criteria: * Lesion with atypia or suspicion of phyllodes (Graded B3 or greater) * Pregnant or lactating women * History of laser or radiation therapy to the targeted breast
References
Publications (0)
Data not yet available
No reference posted for this study.