Clinical Outcomes of the OPEN Clinical Trial: Evaluation of Uterine Patency Following Sonography-Guided Transcervical Radiofrequency Ablation of Fibroids with the Sonata® System

Abstract

Objective: To document the presence or absence of intrauterine adhesions after treatment with the Sonata® System when used in women with submucous and/or transmural fibroids. Design: Post-market prospective, multicenter, single-arm cohort trial, utilizing an independent external hysteroscopy review panel. Settings: Academic and community hospitals in Europe. Patients: Women undergoing transcervical radiofrequency (RF) ablation for symptomatic uterine fibroids. All patients must have at least one FIGO type 1, type 2 or type 2–5 (transmural) fibroid, and a baseline European Society for Hysteroscopy (ESH) adhesion score of 0 as determined by diagnostic hysteroscopy. Interventions: Transcervical, intrauterine ultrasound-guided radiofrequency (RF) ablation of symptomatic uterine fibroids with the Sonata® System followed by second-look hysteroscopy at 6 weeks post-treatment. No adjunctive measures to prevent adhesiogenesis were permitted, nor concomitant procedures that might promote adhesions (eg, dilatation & curettage). Video from each hysteroscopy performed at the baseline and 6-week visits were assessed and scored by two external reviewers, with a third to resolve any disputes. Measurements/Results: Twenty-six patients have been enrolled and treated to date, with completed evaluations (second-look hysteroscopy and baseline and second-look ESH scoring by two readers) available at this time for 13 patients. There were no adhesions noted (ESH scores = 0) for the 13 evaluated second-look hysteroscopies. Conclusions: The literature indicates a varying level (1.5%-78%) of adhesiogenesis associated with hysteroscopic myomectomy and other intrauterine procedures. This may relate to the presence of disruption of the basalis layer of the endometrium. The Sonata System is designed to minimize or avoid disruption of this layer, and preliminary data from the OPEN clinical trial suggest little or no risk of adhesiogenesis.