An interventional study of Ultrasound-Guided Microwave Ablation in Breast Fibroadenoma, sponsored by Al-Azhar University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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
Breast fibroadenoma is a common benign breast tumor, particularly in young women. Many fibroadenomas do not require treatment and can be managed with clinical and ultrasound follow-up. However, treatment may be considered when a fibroadenoma is symptomatic, enlarging, causes cosmetic concerns, or causes significant patient anxiety.
Surgical excision is an effective treatment for symptomatic fibroadenoma, but it may be associated with pain, scarring, changes in breast shape, and other procedure-related complications. These concerns have led to the development of minimally invasive treatment options that aim to treat the fibroadenoma while preserving the surrounding breast tissue.
Microwave ablation is a minimally invasive technique that uses microwave energy to generate heat within the targeted tissue, resulting in tissue destruction. When performed under ultrasound guidance, the treatment can be directed to the fibroadenoma while allowing real-time visualization of the treated area and surrounding breast structures.
This study is designed to evaluate ultrasound-guided microwave ablation as a minimally invasive treatment option for selected adult women with breast fibroadenoma. The study will assess the safety of the procedure and the clinical and cosmetic outcomes following treatment. It will also evaluate changes in pain, patient satisfaction, and the appearance of the treated fibroadenoma during follow-up.
The study may provide additional clinical information about the use of ultrasound-guided microwave ablation as a breast-preserving treatment option for selected patients with breast fibroadenoma.
27 studies on the registry are indexed under Fibroadenoma; 6 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 20 interventional studies indexed under Fibroadenoma.
Browse Fibroadenoma studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The criteria were revised on the registry on Sep 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female patients aged 18 years .
proven breast fibroadenoma by tru-cut .
Symptomatic fibroadenoma or fibroadenoma causing cosmetic concern.
Lesion size suitable for microwave ablation (approximately 1-4 cm).
Patient acceptance of the procedure and written .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Ultrasound-Guided Microwave Ablation
Ultrasound-guided microwave ablation will be performed using a microwave ablation system under real-time ultrasound guidance. The microwave antenna will be positioned within the breast fibroadenoma under ultrasound guidance, and microwave energy will be delivered to the targeted lesion to achieve thermal ablation. The procedure will be performed under local anesthesia. Ablation parameters will be selected according to the characteristics of the lesion and the manufacturer's recommendations.
Procedure-Related Complications
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.
Time frame: Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale
Cosmetic outcome of the treated breast will be assessed using the Harvard Breast Cosmesis Scale during follow-up. The assessment will evaluate the overall cosmetic appearance of the treated breast, including breast shape, contour, symmetry, and the presence of visible treatment-related changes or deformity. The cosmetic outcome will be assessed at each scheduled follow-up visit after ultrasound-guided microwave ablation.
Time frame: 3, 6, and 12 months after treatment
Patient Satisfaction After Microwave Ablation
Patient satisfaction with the treatment outcome will be assessed using a structured patient satisfaction questionnaire during follow-up. The assessment will address the patient's overall satisfaction with the treatment, perceived cosmetic outcome, improvement in symptoms, and acceptance of the procedure as a minimally invasive treatment option.
Time frame: 3, 6, and 12 months after treatment
Pain Severity Assessed by the Visual Analog Scale (VAS)
Pain severity will be assessed using the Visual Analog Scale (VAS). The VAS is a 10-cm scale ranging from 0, indicating no pain, to 10, indicating the worst pain imaginable. Patients will be asked to indicate the intensity of pain experienced before the procedure and during follow-up after ultrasound-guided microwave ablation. Changes in VAS scores over the follow-up period will be assessed to evaluate improvement in pain and local symptoms.
Time frame: Baseline (before the procedure), 3, 6, and 12 months after treatment
Residual Lesion or Lesion Regrowth
Ultrasound will be used to evaluate post-ablation changes, assess the treated fibroadenoma, detect any residual viable tissue, and identify lesion regrowth during follow-up.
Time frame: 3, 6, and 12 months after treatment
Plan to share: No — Individual participant data will not be shared with other researchers. Collected data will be used only for the purposes of this study, with participant confidentiality and privacy maintained.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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