KEY PUBLICATIONS
SONATA Pivotal IDE Trial: 3-Year Results
Lukes A, Green MA. Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata. J Gynecol Surg. 2020;36:5, 228-233.
SONATA Pivotal IDE Trial: 12-Month Results (FDA Submission)
Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas: The SONATA Trial. Obstet Gynecol. 2019; 133(1): 13-22.
Additional Selected Clinical Publications
Römer T, Bends R, Christoffel L, et al. Treatment of Symptomatic Fibroids with Transcervical Ultrasound-guided Radiofrequency Ablation. Indication, procedure, results, and complications—2020 expert consensus. Part 2: Transcervical Radiofrequency Ablation (TRFA)–Methods, indications, results, and comparison with other therapies. Frauenarzt. 2021;162-168.*
Christoffel L, Römer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Med Devices (Auckl). 2021;14:77-84.
Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata® system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021;79-85.
Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study. Journal of Gynecologic Surgery. 2019; 35:19-23.
Brölmann H, Bongers M, Garza-Leal J, Gupta J, et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016; 13: 27-35.
Taheri M, Galo L, Potts C, Sakhel K, Quinn SD. Nonresective treatments for uterine fibroids: a systematic review of uterine and fibroid volume reductions. International Journal of Hyperthermia. 2019; 1-7.
Huirne J, Brooks E. Improvement in health utility after transcervical radiofrequency ablation of uterine fibroids with the Sonata System: Health utility after radiofrequency ablation. Eur J Obstet Gynecol Reprod Biol. 2018; 224: 175-180.
Toub, DB. A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System. Curr Obstet Gynecol Rep. 2017;6(1):67-73.
Bongers M, Brölmann H, Gupta J, Garza-Leal JG, Toub D. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study. Gynecol Surg. 2015;12(1):61-70.
Jones, S., O'Donovan, P, Toub, D, Radiofrequency Ablation for Treatment of Symptomatic Uterine Fibroids. Obstet Gynecol Int. 2012;194839.
Garza-Leal, JG, Toub, D, León, IH, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting. Gynecol Surg. 2011; 8: 327.
*Translated from original German publication. Römer T, Bends R, Christoffel L, et al. Behandlung von symptomatischen Myomen mit der transzervikalen ultraschallgesteuerten Radiofrequenzablation-Indikationen, Durchführung, Ergebnisse und Komplikationen-Expertenkonsensus 2020. Teil 2: Die transzervikale Radiofrequenzablation (TRFA) – Methode, Indikationen, Ergebnisse und Vergleich mit anderen Therapien. Frauenarzt. 2021;162-168.
