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Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes

Study acronym: MWA-FA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 27 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07823907
Lead Sponsor Al-Azhar University
Conditions
(from sponsor)
Breast Fibroadenoma
Related terms Fibroadenoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov