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# IDE OK’d for Robotic Prostate Cancer Surgery
- URL: https://www.fdaweb.com/ide-okd-for-robotic-prostate-cancer-surgery/
- Published: 2024-10-09T12:00:00.000Z
- Updated: 2026-09-14T14:43:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157946

FDA has approved a Procept BioRobotics IDE for a clinical trial comparing its Aquablation therapy to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. The trial, WATER IV PCa, will enroll up to 280 patients at up to 50 centers and follow them for 10 years, according to the company. 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, it adds.

Procept says Aquablation is the first ultrasound-guided, robotic-assisted, heat-free waterjet for treating benign prostatic hyperplasia. The device’s real-time imaging “provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy,” it says. “The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.”