Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results

Study Objective To describe the protocol and preliminary results of SAGE Registry, which characterizes long-term (5-year) outcomes transcervical fibroid ablation (TFA) with Sonata® System when used to treat symptomatic uterine fibroids in real-world use. Design Ongoing post-market global registry. Setting Up 50 clinical sites. Patients or Participants 500 women who select TFA Sonata for treatment fibroids. Interventions Transcervical Measurements Main Results include changes symptom severity score health-related quality life subscales UFS-QoL, general health status on EQ-5D, perceived benefit, satisfaction, work activity patterns, overall patient outcome, adverse events, pregnancy incidence outcomes, surgical reinterventions heavy menstrual bleeding. One Hundred Sixty (160) have been enrolled treated date, a device-related event rate 0.6% serious procedure-related 0.6%. Of 241 ablated, 10% were submucous, 52% transmural, 28% intramural, subserous. Ablated diameters ranged from <1 cm >10 cm, 27% having maximum >5 cm. Conclusion The registry represents largest known study will generate up 2500 patient-years outcome data. Preliminary first 160 suggest broad applicability wide range types sizes, including those > 5 an excellent safety profile. repertoire SAGE, subserosal fibroids, are not generally accessible operative hysteroscopy.