RELIEF registry: large-scale evidence on the safety and long-term efficacy of focused ultrasound treatment of symptomatic leiomyoma
© Hananel et al; licensee BioMed Central Ltd. 2015
Published: 30 June 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.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.