本臨床試驗的目的是了解高強度聚焦超聲（HIFU）治療18至50歲女性症狀性子宮肌瘤是否與子宮肌瘤切除術同樣有效。其主要探討的問題包括： HIFU在改善子宮肌瘤女性生活質素方面是否與子宮肌瘤切除術同樣有效？HIFU與子宮肌瘤切除術的恢復時間及併發症如何比較？
適應症：Uterine Fibroids (UF)
收案條件
納入條件
- Age 18 - 50 years-old
- Pre or peri menopausal with FSH less than 25 mIU/ml
- BMI \< 33 kg/m2 or abdominal wall thickness \< 5 cm
- Uterine size ≤18 weeks based on physical exam assessment
- Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging
- Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain
- Willing and able to give informed consent
排除條件
- Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease
- Morbid obesity
- Inability to lie in a prone position for more than 2 hours
- Extensive abdominal scar on the acoustic channel
- Women with pregnancy, lactation or menopause
- Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI
- Rapid growth of fibroids, defined as a doubling in size in 6 months
- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- Coagulation problem or using medication which affect clotting function
- History of pelvic irradiation
- Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter
- Cervical/ broad ligament fibroid
- Contraindication to MRI due to severe claustrophobia or implanted metallic device.
- Co-existing adenomyosis
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。