Abstract The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauter-ine sonography-guided radiofrequency ablation with the
VizAblate™System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, andMexico. Women with qualify-ing uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as
assessed by contrast-enhancedMRI at 3months by an indepen-dent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Men-strual Pictogram (MP) score, and the Symptom Severity Score
(SSS) subscale of theUterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assess-ments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for ab-normal uterine bleeding, anesthesia regimen, patient satisfac tion, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofre-quency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from base-line by an average of 68.1±28.6 and 67.4±31.9 %, respective-ly, while total fibroid volumes were reduced from baseline by an average of 54.7±37.4 and 66.6±32.1 %, respectively (all P