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

Abstract

<h3>Study Objective</h3> To describe the protocol and preliminary results of the SAGE Registry, which characterizes the long-term (5-year) outcomes of transcervical fibroid ablation (TFA) with the Sonata® System when used to treat symptomatic uterine fibroids in real-world use. <h3>Design</h3> Ongoing post-market global registry. <h3>Setting</h3> Up to 50 clinical sites. <h3>Patients or Participants</h3> Up to 500 women who select TFA with the Sonata System for treatment of symptomatic uterine fibroids. <h3>Interventions</h3> Transcervical fibroid ablation in women with symptomatic uterine fibroids. <h3>Measurements and Main Results</h3> Main outcomes include changes in the symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding. One Hundred Sixty (160) women have been enrolled and treated to date, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of 241 fibroids ablated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having maximum diameters >5 cm. <h3>Conclusion</h3> The SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes, including those with diameters > 5 cm, and an excellent safety profile. The wide repertoire of fibroid types treated in SAGE, including transmural, intramural, and subserosal fibroids, are not generally accessible to operative hysteroscopy.