PROCEPT BioRobotics Corporation announced on October 7, 2024, that the U.S. Food and Drug Administration (FDA) approved a pivotal Investigational Device Exemption (IDE) clinical trial for its Aquablation therapy. This trial, known as WATER IV PCa, will compare Aquablation therapy to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer.
The company also received Breakthrough Device Designation for Aquablation therapy for prostate cancer, which expedites the review of novel therapies for life-threatening or irreversibly debilitating conditions. The WATER IV PCa study is a global multicenter, prospective, randomized clinical trial designed to enroll up to 280 patients at up to 50 centers and will follow them for 10 years.
This initiative represents a significant opportunity to improve safety and quality of life outcomes for men with prostate cancer, potentially establishing Aquablation therapy as a first-line treatment. The trial's co-primary endpoint focuses on morbidity at six months, with longer-term follow-up assessing harm reduction and oncologic events.
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