Breast FibroadenomaMWA-FANCT07823907
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
A study testing Ultrasound-Guided Microwave Ablation in people with Breast Fibroadenoma, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- Ultrasound-Guided Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Azhar University Hospitals - Assiut
Asyut, 71524
mohammad omar selmy, M.B.B.Ch., +201090190759, apoomar4455@gmail.com
apoomar4455@gmail.com
About this study
Official title: Ultrasound-Guided Microwave Ablation for Treatment of Breast Fibroadenoma: Prospective Evaluation of Safety and Cosmetic Outcome
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:
Read more
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
Read the detailed description
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.
- Conditions
- Breast Fibroadenoma
- Being tested
- Ultrasound-Guided Microwave Ablation
- Keywords
- Breast Fibroadenoma, Microwave Ablation
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Microwave AblationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation | Experimental | 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. Receives: Device: Ultrasound-Guided Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3, 6, and 12 months after treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3, 6, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FibroadenomaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-group, single-arm interventional study. All enrolled participants will receive ultrasound-guided microwave ablation for the treatment of breast fibroadenoma. There will be no control or comparator group. Participants will be evaluated prospectively for safety, clinical outcomes, cosmetic outcome, pain, patient satisfaction, and ultrasound findings during follow-up.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Omar Mohammad Selmy, Al-Azhar University
- Investigators
- tarek m mansour, MD, Principal investigator, Al-Azhar University, Faculty of Medicine, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823907
- Sponsor's protocol ID
- Diag.I.Rad-900/2026/09/008
- Acronym
- MWA-FA
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Microwave Ablation for Treatment of Breast Fibroadenoma: Prospective Evaluation of Safety and Cosmetic Outcome
- ClinicalTrials.gov ID
- NCT07823907
- Acronym / sponsor ID
- MWA-FA / Diag.I.Rad-900/2026/09/008
- Conditions
- Breast Fibroadenoma
- Keywords
- Breast Fibroadenoma, Microwave Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-group, single-arm interventional study. All enrolled participants will receive ultrasound-guided microwave ablation for the treatment of breast fibroadenoma. There will be no control or comparator group. Participants will be evaluated prospectively for safety, clinical outcomes, cosmetic outcome, pain, patient satisfaction, and ultrasound findings during follow-up.
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation | Experimental | Device: Ultrasound-Guided Microwave AblationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Suspicious or malignant breast lesion.
- Pregnancy.
- Coagulopathy or bleeding tendency.
- Active breast infection.
- Lesion with direct adherence to or involvement of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Microwave AblationUltrasound-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. | Device | Microwave Ablation |
Primary outcome
Procedure-Related Complications
Time frame: Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
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.
Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale
Time frame: 3, 6, and 12 months after treatment
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.
Patient Satisfaction After Microwave Ablation
Time frame: 3, 6, and 12 months after treatment
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.
2 secondary outcomes
Pain Severity Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline (before the procedure), 3, 6, and 12 months after treatment
Residual Lesion or Lesion Regrowth
Time frame: 3, 6, and 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Breast Fibroadenoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
tarek m mansour, MD principal investigator
Al-Azhar University, Faculty of Medicine, Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Microwave Ablation in people with Breast Fibroadenoma, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohammad omar selmy, M.B.B.Ch (+201090190759, apoomar4455@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-Related Complications (time frame: Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.