EDAP TMS Publishes HIFI Study Results In European Urology
EDAP TMS Publishes HIFI Study Results In European Urology
edap tms在《欧洲泌尿科学杂志》发布HIFI研究结果
- HIFI Study is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments
- Positive study results are expected to drive further adoption of Focal One as a first line treatment option for the management of localized prostate cancer
- Study shows Focal One Robotic HIFU is non-inferior to surgery, meeting primary endpoint of non-inferiority for Salvage Treatment-free Survival (STFS) after High Intensity Focused Ultrasounds (HIFU) compared to Radical Prostatectomy (RP) at 30 months
- Study shows that patients receiving HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving RP
- HIFI研究是迄今为止进行的最大规模（N = 3,328）的前瞻性、比较性、多中心临床研究，比较前列腺癌治疗方案。
- 积极的研究结果预计将推动Focal One作为局部前列腺癌管理的首选治疗方案的进一步采用。
- 研究表明，Focal One机器人高强度聚焦超声（HIFU）在非劣效性方面不逊于手术，满足高强度聚焦超声（HIFU）后救治治疗无生存期（STFS）的主要终点，与根治性前列腺切除术（RP）相比较，在30个月内。
- 研究表明，与接受根治性前列腺切除术（RP）的患者相比，接受HIFU的患者在尿失禁和勃起功能方面的结果更好。
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