Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial).

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 Sonata® system. 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. 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. 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.

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