Focus of the Report: This report focuses on the transcervical radiofrequency ablation (RFA) with the Sonata system for treatment of symptomatic uterine fibroids (UF).
Technology Description: The Sonata system (formerly the VizAblate system) (Gynesonics Inc.) is a minimally invasive, uterine-sparing, ultrasound-guided system for performing transcervical RFA of fibroids in the outpatient setting.
Controversy: Controversies pertinent to the evaluation of treatments for symptomatic UF include whether there is a strong correlation between reductions in fibroid volume and symptom relief. In addition, the efficacy and safety of transcervical RFA in comparison with other clinical alternatives, particularly other uterine-sparing technologies such as UAE and MRgFUS are unresolved. Pertinent to transcervical RFA of UF is whether this treatment is effective and safe for women who wish to reduce symptoms related to UF yet wish to maintain fertility compared with minimally invasive procedures (e.g., UAE) or surgical procedures (e.g., myomectomy).
Is transcervical RFA with the Sonata System effective for treating UF?
How does transcervical RFA with the Sonata System compare with other treatments of symptomatic UF?
Is transcervical RFA with the Sonata System safe?
Have definitive patient selection criteria been identified for transcervical RFA with the Sonata System for the treatment of symptomatic UF?
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