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Touro College of Osteopathic Medicine (New York) Publications and Research
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12-Month Outcomes Of The Us Patient Cohort In The Sonata Pivotal Ide Trial Of Transcervical Ablation Of Uterine Fibroids., Joseph Hudgens, D. Alan Johns, Andrea S. Lukes, David A. Forstein, Dipak Delvadia
12-Month Outcomes Of The Us Patient Cohort In The Sonata Pivotal Ide Trial Of Transcervical Ablation Of Uterine Fibroids., Joseph Hudgens, D. Alan Johns, Andrea S. Lukes, David A. Forstein, Dipak Delvadia
Touro College of Osteopathic Medicine (New York) Publications and Research
Objective: The prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort.
Methods: TFA with the Sonata System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical reintervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated.
Results: One hundred twenty-five …