- Oral presentation
- Open Access
RELIEF registry: large-scale evidence on the safety and long-term efficacy of focused ultrasound treatment of symptomatic leiomyoma
Journal of Therapeutic Ultrasoundvolume 3, Article number: O94 (2015)
In this work we will present our plan for an (MR)-guided, high-intensity focused ultrasound (FUS) uterine fibroid registry, with the goal of providing large-scale evidence on the safety and long-term efficacy of FUS for the treatment of symptomatic uterine fibroids.
1,000 patients will be enrolled to the registry in multiple sites worldwide. Patient would get FUS treatment and be followed for a period of three years. Only FUS qualified patients and sites meeting registry treatment criteria would participate in the study.
Results and conclusions
Treatment outcome and follow-up data will be collected by a contract research organization, (CRO), and analyzed for safety and efficacy. We will then compare our results to similar results in the literature. Subgroups will be selected and analyzed to address heterogeneity and usage of non-uniform treatment methods.