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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03125889

Acronym

AHA II

Enrollment

Registered

2017-04-24

Start date

2017-04-10

Completion date

2017-07-07

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 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 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.

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 * BPH symptoms

Exclusion criteria

* Serious concurrent medical conditions

Design outcomes

Primary

Measure	Time frame
Completion of the intended surgical procedure with adequate hemostasis	7 days post-op
Proportion of subjects who return to the OR for bleeding treatment or requires transfusion	7 days post-op

Countries

India

Outcome results

None listed

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