NCT07890766Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Management of Breast Fibroadenoma; Multidisciplinary Approach: A Comparative Interventional Study Evaluating Conservative Management, Ultrasound-Guided Microwave Ablation, and Conventional Surgical Excision
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate and compare three different management strategies for benign breast fibroadenoma: conservative management with clinical and radiological follow-up (observation), ultrasound-guided percutaneous microwave ablation (MWA), and conventional open surgical excision. Fibroadenoma is the most common benign solid breast tumor in young women. While conventional surgical excision provides complete tissue removal, it may result in visible surgical scars, breast volume loss, and contour deformity. Minimally invasive thermal techniques such as microwave ablation offer potential advantages in tissue preservation and cosmetic satisfaction under local anesthesia. This study aims to assess and compare the therapeutic success, safety, postoperative pain, recovery period, complication rates, and cosmetic outcomes among female patients undergoing these three approaches at Sohag University Hospital.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- May 2027
- Lead sponsor
- Sohag University
- NCT number
- NCT07890766
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Nov 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ipsilateral breast surgery, radiotherapy, or ablative procedure.
- Presence of breast implants.
- Severe uncorrectable coagulopathy or clinical unfitness for interventional/surgical procedure.
Other illness
- Histological features of phyllodes tumor, cellular atypia, or malignancy on core needle biopsy.
Other
- BI-RADS category 4 or higher on pre-procedure imaging.
- Pregnancy or current lactation.
Who the study is looking for
- Female patients aged 18 to 40 years.
- Histologically confirmed breast fibroadenoma on ultrasound-guided core needle biopsy with concordant imaging features classified as BI-RADS 2 or 3.
- Lesion size of 1.0 cm to 4.0 cm in maximum diameter on baseline ultrasound measurement.
- Lesion requiring active intervention based on at least one of: documented progressive growth during surveillance, local symptoms (pain, discomfort, or compression), cosmetic concern, or patient preference/refusal of further conservative management.
- Minimum distance of 1.0 cm from the lesion to the skin surface, nipple-areola complex, and pectoralis fascia on ultrasound in the supine position.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sohag University Hospital Coordinator of this site? Confirm its status | Sohag | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.