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Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia — AHA  

Benign Prostatic Hyperplasia Clinical Trial

Official title:
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

Clinical Trial Summary

A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.

Clinical Trial Description

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 Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03125863
Study type Interventional
Source PROCEPT BioRobotics
Contact
Status Completed
Phase N/A
Start date August 26, 2016
Completion date July 31, 2017
View Details
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