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NCT07823907
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
Conditions: Breast Fibroadenoma
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Al-Azhar University
Location: Al-Azhar University Hospitals - Assiut Asyut
Summary
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07823907). StuddyBuddy aggregates publicly available trial information.