Benign Prostatic Hyperplasia Clinical Trial
Official title:
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis following prostate resection using the AQUABEAM for treatment of LUTS resulting from BPH.
PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial. ;
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