OBJECTIVES: Uterine fibroids often lead to symptoms that negatively impact health-related quality of life (HRQOL). High-intensity focused ultrasound (HIFU) has emerged as a promising noninvasive treatment for reducing fibroid size and symptoms. The Mirabilis system for ultrasound (US)-guided HIFU introduces a novel technique known as 'shell ablation'. This study evaluates the feasibility and efficacy of Mirabilis in a clinical setting, focusing on clinical outcomes. MATERIALS AND METHODS: Sixteen patients with 23 uterine fibroids were treated with the Mirabilis system. Follow-up assessments included US and MRI at baseline, 6 weeks, 3, 6 and 9 months, and 1 year after HIFU. Changes in symptoms and QOL were evaluated using the Uterine Fibroid Symptom and HRQOL Questionnaire. RESULTS: A significant reduction in fibroid volume was observed after HIFU (baseline 182.1 ± 49.3 ml
1 year: 76.0 ± 37.9 ml, p <
0.001). The symptom severity score significantly declined (baseline 57.2 ± 3.8
1 year: 30.2 ± 4.9, p <
0.001), correlating with a significant improvement in HRQOL (baseline 47.0 ± 3.9, 1 year: 71.8 ± 5.3, p <
0.001). CONCLUSION: HIFU with the portable Mirabilis system is a feasible and safe noninvasive treatment for symptomatic uterine fibroids in an outpatient setting. This approach allows efficient and rapid ablation even for large fibroids, significantly reducing fibroid volume and symptoms.