PROCEPT BioRobotics Says FDA Has Approved Pivotal Investigational Device Exemption Clinical Trial Comparing Aquablation Therapy To Radical Prostatectomy
PROCEPT BioRobotics Says FDA Has Approved Pivotal Investigational Device Exemption Clinical Trial Comparing Aquablation Therapy To Radical Prostatectomy
The Company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. Breakthrough Device Designation is awarded in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.
公司最近還獲得了突破性裝置指定，以研究Aquablation療法用於前列腺癌的使用。突破性裝置指定在特殊情況下授予，加速審核能夠改善生命受威脅或無法逆轉的疾病或病況患者生活質量的新療法。
The trial, known as WATER IV PCa, is a global multicenter, prospective, randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer.
名爲WATER IV PCa的試驗是一個全球性多中心、前瞻性、隨機對照臨床研究，評估Aquablation療法與激光根治術在級別組1至3局部前列腺癌男性患者中的安全性和有效性。
The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years. There is a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up focuses on both the reduction in treatment related harm and oncologic events.
該研究將招募多達280名患者，在多達50箇中心進行隨訪長達10年。主要終點有兩個，其中一個基於術後六個月的病態評估。較長期的隨訪將側重於減少與治療相關的危害和腫瘤事件。
