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The Sonablate International HIFU Registry (SHIR) is the first worldwide registry to gather information about prostate cancer treatment using HIFU. It was established to offer a single, secure, standardized repository of treatment information for users of the Sonablate® technology. It has been developed by physicians and is for physicians. US HIFU is a co-sponsor of the Registry, along with co-sponsors Misonix, Inc. and Takai Hospital Supply Co., Ltd.(THS).
The SIHR is a truly independent database; it is stored in a secure online environment by an independent IT company. The information gathered will be reviewed and analyzed by independent, third-party statisticians. At no point do the sponsoring organizations have access to the raw dataset. Registry oversight will be provided by a steering committee consisting of senior Sonablate® HIFU users from five different countries, including Mark Emberton, M.D., London, England; Rowland Illing, M.D., London, England; Stephen Scionti, M.D., Hilton Head, SC; Michael Marberger, M.D., Vienna, Austria; and Prof. Toyoaki Uchida, Tokyo, Japan.
The concept of a HIFU registry was formulated to address several areas:
- Provide the treating physician with his/her own registry of patients, to allow assessment of outcomes and to optimize treatment decisions
- Offer a non-limiting framework and guidelines for data collection
- Allow an assessment of oncological effectiveness and safety in a "real life" setting, taking into account patients who might be otherwise unsuitable for inclusion in a clinical trial
- Provide quality assurance and a structure for continuing medical education
- Facilitate knowledge expansion in the field of transrectal HIFU by defining determinants of outcome, and to enable the publication of results on an individual and worldwide level
- Build relations between physicians using this technology
- Provide state-of-the-art tools for a novel therapy which allow evidence based data analysis and presentation
The developers and clinicians have been presented with a unique opportunity: the chance to establish a registry which would encompass all new users before the mainstream uptake of this technology. As this is achieved and seamlessly incorporated into the training program, it will become a model for all future new surgical procedures.
For more information on the HIFU Registry and to log on, please visit http://www.hifu-registry.com/index.html.
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