Clinical trial · Interventional
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
Ultrasound-Guided Microwave Ablation for Treatment of Breast Fibroadenoma: Prospective Evaluation of Safety and Cosmetic Outcome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if ultrasound-guided microwave ablation is a safe and effective treatment for breast fibroadenoma in adult women. It will also learn about the cosmetic outcome and patient satisfaction after treatment. The main questions it aims to answer are: What medical problems or complications do participants have after microwave ablation? Does the treated breast fibroadenoma decrease in size during follow-up? Does pain improve after treatment? What are the cosmetic outcomes and how satisfied are participants with the treatment? Researchers will evaluate the treated fibroadenoma using clinical examinations and breast ultrasound during 12 months of follow-up. Participants will: Have a clinical examination, breast ultrasound, and core needle biopsy before treatment Receive ultrasound-guided microwave ablation under local anesthesia Have follow-up visits at 3, 6, and 12 months after treatment Have breast ultrasound examinations during follow-up Have their pain, treatment-related complications, cosmetic outcome, and satisfaction assessed during follow-up
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 |
|---|---|---|---|
| Ultrasound-Guided Microwave Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave Ablation
- description
- Participants in this arm will receive ultrasound-guided microwave ablation for the treatment of breast fibroadenoma. Microwave ablation will be performed under local anesthesia using real-time ultrasound guidance to target the fibroadenoma.
- interventionNames
- Device: Ultrasound-Guided Microwave Ablation
Primary outcomes (3)
- measure
- Procedure-Related Complications
- timeFrame
- Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
- description
- The occurrence and type of procedure-related complications following ultrasound-guided microwave ablation of breast fibroadenoma will be assessed, including immediate and delayed complications such as pain, bleeding, hematoma, skin injury, infection, and other procedure-related adverse events.
- measure
- Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Female patients aged 18 years . Histologically proven breast fibroadenoma by tru-cut biopsy. Symptomatic fibroadenoma or fibroadenoma causing cosmetic concern. Lesion size suitable for microwave ablation (approximately 1-4 cm). Patient acceptance of the procedure and written informed consent. Exclusion Criteria: Suspicious or malignant breast lesion. Pregnancy. Coagulopathy or bleeding tendency. Active breast infection. Lesion with direct adherence to or involvement of the skin. Lesion unsuitable for safe antenna placement. Patient refusal to participate or inability to complete follow-up. * Lesion with direct adherence to or involvement of the skin. * Lesion unsuitable for safe antenna placement. * Patient refusal to participate or inability to complete follow-up.
References
Publications (0)
Data not yet available