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.
公司最近还获得了突破性装置指定，以研究Aquablation疗法用于前列腺癌的使用。突破性装置指定在特殊情况下授予，加速审核能够改善生命受威胁或无法逆转的疾病或病况患者生活质量的新疗法。
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.
名为WATER IV PCa的试验是一个全球性多中心、前瞻性、随机对照临床研究，评估Aquablation疗法与激光根治术在级别组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.
该研究将招募多达280名患者，在多达50个中心进行随访长达10年。主要终点有两个，其中一个基于术后六个月的病态评估。较长期的随访将侧重于减少与治疗相关的危害和肿瘤事件。
