Monday, November 28, 2022

PROCEPT BioRobotics Announces Multi-Center, Real World Clinical Study Outcome

One-year Results from the OPEN WATER Trial is Published in the Journal of Clinical Medicine

PROCEPT BioRobotics Corporation, a surgical robotics company developing intelligent solutions to transform the field of urology, has announced that the safety and efficacy outcomes from a multi-center study of Aquablation therapy replicated those achieved in its pivotal clinical trials.

Aquablation therapy is a procedure for the treatment of benign prostatic hyperplasia (BPH), and is performed by the AquaBeam® Robotic System, the first FDA cleared, automated surgical robot for the treatment of this common condition.

“This study provided a very important validation of Aquablation therapy, as this is the first multi-center publication of outcomes in a commercial setting,” said Reza Zadno, president and CEO of PROCEPT BioRobotics. “These findings not only confirm the outcomes we saw in our landmark clinical trials but will also help encourage acceptance and adoption of Aquablation therapy as a new BPH treatment of choice for all prostates, in markets worldwide.”

OPEN WATER was a prospective, multicenter, single-arm, open-label clinical trial of the Aquablation procedure. One hundred and seventy-eight men with prostates sized between 20 and 150 cc were enrolled between September 2017 and December 2018 across five geographies, including Hamburg, Germany; Tauranga, New Zealand; Beirut, Lebanon; Melbourne, Australia; and Frimley, England. Open Water demonstrated large improvements at 12 months in symptom relief and peak urinary flow rates while preserving sexual function and urinary continence.

The study data, which were published in the Journal of Clinical Medicine, demonstrated large improvements at 12 months in symptom relief and peak urinary flow rates while preserving sexual function and urinary continence. Similar levels of symptom relief were seen independent of surgical experience. Moreover, the authors reported that no patient underwent a secondary procedure for recurrent BPH symptoms.

“As noted in our paper, the OPEN WATER study results indicate that the Aquablation procedure provides high levels of symptom relief, consistent with most resective techniques, but with an approximately eight times lower impact on sexual function,” said lead author Prof. Thorsten Bach, Asklepios Westklinikum Hamburg-Rissen. “The magnitude of symptom relief combined with such low rates of sexual dysfunction should give confidence to every urologist considering the adoption of Aquablation therapy in his or her practice.”

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