Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes (MWA-FA)
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:
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: mohammad omar selmy, M.B.B.Ch
- Numer telefonu: +201090190759
- E-mail: apoomar4455@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Ahmed Abd-Elrady Ahmed, MD
- Numer telefonu: +201005781485
- E-mail: drahmedazkool@gmail.com
Lokalizacje studiów
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Asyut, Egipt, 71524
- Al-Azhar University Hospitals - Assiut
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Kontakt:
- mohammad omar selmy, M.B.B.Ch.
- Numer telefonu: +201090190759
- E-mail: apoomar4455@gmail.com
-
Kontakt:
- E-mail: apoomar4455@gmail.com
-
Główny śledczy:
- mohammad omar selmy, M.B.B.Ch.
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Główny śledczy:
- Tarek Mohammad Mansour, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
inclusion Criteria:
Female patients aged 18 years or older. 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Microwave Ablation
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Procedure-Related Complications
Ramy czasowe: Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
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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.
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Complications will be assessed immediately after the procedure and during the 3-, 6-, and 12-month follow-up visits.
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Cosmetic Outcome Assessed by the Harvard Breast Cosmesis Scale
Ramy czasowe: 3, 6, and 12 months after treatment
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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.
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3, 6, and 12 months after treatment
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Patient Satisfaction After Microwave Ablation
Ramy czasowe: 3, 6, and 12 months after treatment
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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.
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3, 6, and 12 months after treatment
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain Severity Assessed by the Visual Analog Scale (VAS)
Ramy czasowe: Baseline (before the procedure), 3, 6, and 12 months after treatment
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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.
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Baseline (before the procedure), 3, 6, and 12 months after treatment
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Residual Lesion or Lesion Regrowth
Ramy czasowe: 3, 6, and 12 months after treatment
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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.
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3, 6, and 12 months after treatment
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: tarek mohammad mansour, MD, Al-Azhar University, Faculty of Medicine, Assiut
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Diag.I.Rad-900/2026/09/008
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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