1630 12-Month Outcomes of the Us Patient Cohort in the Sonata Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids

Study Objective The SONATA trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical radiofrequency ablation in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort. Design Prospective, longitudinal, multicenter, single-arm trial. Setting 21 clinical sites in the US. Patients or Participants Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions Transcervical, intrauterine radiofrequency ablation was performed on ≤10 uterine fibroids from 1 to 5 cm in diameter with the Sonata® system. Twelve-month co-primary endpoints were reduction in menstrual bleeding and rate of surgical reintervention. Symptom severity, quality of life, satisfaction, safety, and fibroid volume reduction were also evaluated. Measurements and Main Results 125 patients were enrolled/treated in the US. Both IDE trial co-primary endpoints were achieved, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively). Mean maximal fibroid volume reduction per patient was 63.8%. There were no device related adverse events. Mean length of stay was 2.5 hours and 50% of patients returned to normal activity within 1 day. Conclusion This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. Treatment with the Sonata system significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of Sonata as a first-line treatment for women affected by symptomatic uterine fibroids.