Full length article Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial) Marlies Bongers a,b, *, Stephen D. Quinn c,d , Michael D. Mueller e , Bernhard Krämer f , Benjamin Tuschy g , Marc Sütterlin g , Ricardo Bassil Lasmar h , Scott Chudnoff i , Andreas Thurkow j , Rudy Leon De Wilde k,l a Máxima Medisch Centrum, Veldhoven, the Netherlands b Grow-School for Oncology and Developmental Biology, Maastricht University, Maastricht, the Netherlands c Imperial College, London, United Kingdom d St. Mary's Hospital, London, United Kingdom e Universitätsspital Bern, Bern, Switzerland f University of Tübingen, Tübingen, Germany g University Medical Centre Mannheim, Heidelberg University, Mannheim, Germany h Department of Gynecology, Federal Fluminense University–UFF, Niterói, Brazil i Obstetrics and Gynecology, Stamford Hospital. Stamford, Connecticut, United States j Amsterdam University Medical Centre, Amsterdam, the Netherlands k University Hospital for Gynecology, Pius-Hospital, University Medicine Oldenburg, Germany l Carl von Ossietzky University Oldenburg, Germany A R T I C L E I N F O Article history: Received 3 March 2019 Received in revised form 4 September 2019 Accepted 18 September 2019 Keywords: Fibroids Intrauterine adhesions Radiofrequency ablation Sonata Intrauterine sonography A B S T R A C T Objective: Standard transcervical fibroid treatment via hysteroscopic myomectomy can result in a significant rate of intrauterine adhesiogenesis. The primary objective of this study was to document the incidence of de novo uterine adhesions after transcervical fibroid ablation (TFA) of symptomatic uterine fibroids with the Sonata1 system. Study design: In this European postmarket prospective, multicenter, single-arm interventional trial, patients were eligible for inclusion if they chose TFA with the Sonata System for symptomatic fibroids and had at least 1 type 1, type 2 or type 2–5 myoma. The presence or absence of intrauterine adhesions was assessed by diagnostic hysteroscopy at baseline and at 6 weeks post-ablation. The hysteroscopy videos were scored by a committee of 3 independent readers. Results: A total of 6 sites enrolled 37 patients. Fifty fibroids with a mean diameter of 3.4  1.8 cm (range 1–8 cm) were ablated. Of the 37 enrolled subjects, 35 completed the study follow-up and 2 electively withdrew from the study prior to the completion of study follow-up. Thirty-four out of 35 pairs of baseline and 6-week hysteroscopies were evaluated by the independent readers with none having de novo adhesions at 6 weeks after treatment with Sonata, including 6 patients with apposing myomata. One patient was excluded from the analysis due to an unevaluable hysteroscopy video. Conclusion: Intrauterine adhesiogenesis was not seen post-TFA with the Sonata system. These results suggest the potential for adhesiogenesis after TFA, including in women with apposing submucous and/or transmural myomata, may be minimal. © 2019 Elsevier B.V. All rights reserved. Introduction Uterine fibroids are the most common benign tumors in women, occurring in approximately 20–50% of premenopausal women, and the prevalence increases with age [1]. In White women, the lifetime risk of developing fibroids is as high as 70% and in black women as high as 80% [2]. Based on a 2010 population estimate, approximately 588,164 women seek treat- ment for symptomatic uterine fibroids annually in the United States [3]. Although often asymptomatic, uterine fibroids may cause a number of symptoms such as heavy menstrual bleeding, dyspareunia, dysmenorrhea, pelvic/abdominal pressure and subfertility. Uterine fibroids can negatively impact quality of life and are commonly associated with invasive and expensive treatments [4]. * Corresponding author at: Máxima Medisch Centrum, Postbus 7777, 5500 MB Veldhoven, the Netherlands. E-mail address: m.bongers@mmc.nl (M. Bongers). https://doi.org/10.1016/j.ejogrb.2019.09.013 0301-2115/© 2019 Elsevier B.V. All rights reserved. European Journal of Obstetrics & Gynecology and Reproductive Biology 242 (2019) 122–125 Contents lists available at ScienceDirect European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.else vie r.com/locat e/e jogrb