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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03125863

Acronym

AHA

Enrollment

Registered

2017-04-24

Start date

2016-08-26

Completion date

2017-07-31

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics

Brief 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.

Detailed 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.

Interventions

DEVICEAquaBeam System

The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Male age from 40 through 85 years with LUTS due to BPH

Exclusion criteria

* Any severe illness that would prevent complete study participation or confound study results

Design outcomes

Primary

Measure	Time frame
Completion of the intended surgical procedure	7 days post-op
Proportion of subjects that require electrocautery or any other intervention post catheter removal.	7 days post-op

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026