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Objective:  The aim of this research was to evaluate uterine-wall integrity 12 months after transcervical fibroid ablation (TFA) of uterine fibroids with the Sonata ® system (Gynesonics Inc., Redwood City, CA).  Materials and Methods:  INTEGRITY is a secondary analysis of the FAST-EU clinical trial, a prospective, longitudinal, multicenter single-armed trial involving women with heavy menstrual bleeding secondary to fibroids who were treated at 7 academic and community hospitals in the United Kingdom, the Netherlands, and Mexico with transcervical, intrauterine, ultrasound-guided radiofrequency ablation (the Sonata system). TFA was performed on up to 5 fibroids per subject ranging from 1-5 cm in diameter as determined by magnetic resonance imaging (MRI). All measurements and comparisons, including uterine-wall thicknesses were derived from baseline and 12-month MRI scans by an independent core MRI center. Scans were analyzed to assess preservation of uterine-wall integrity and reviewed for uterine-wall anomalies after TFA with the Sonata system.  Results:  Twenty-nine patients had baseline and 12-month MRI with contrast enhancement. Minimum uterine-wall thicknesses in all visible slices were &gt;2.5 mm in diameter. No areas on MRI indicated any loss of uterine-wall integrity, compared with baseline imaging; comparison of baseline and postablation uterine-wall thicknesses revealed no significant changes.  Conclusion:  Transcervical fibroid ablation with the Sonata system was associated with preservation of uterine-wall integrity in this patient cohort.

The INTEGRITY Trial: Preservation of Uterine-Wall Integrity 12 Months After Transcervical Fibroid Ablation with the Sonata System