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

Sponsor

PROCEPT BioRobotics (Industry)

Overall Status

Completed

CT.gov ID

NCT04308070

Collaborator

(none)

Enrollment

Location

Arms

11.4

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A dual-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent following treatment with the AQUABEAM System.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: AQUABEAM System followed by catheter without hemostatic agent Device: AQUABEAM System followed by catheter with hemostatic agent	N/A

Detailed Description

PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue in males suffering from LUTS due to BPH. The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis using balloon catheters with and without hemostatic agents 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 3 months for safety assessment prior to study exit. The trial is a dual-arm prospective, interventional clinical trial.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 18, 2017

Actual Primary Completion Date :

Mar 22, 2018

Actual Study Completion Date :

Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheter without Hemostatic Agent Following Aquablation AQUABEAM System followed by catheter without hemostatic agent	Device: AQUABEAM System followed by catheter without hemostatic agent The AquaBeam system delivers a high-pressure 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 physician will use balloon catheter to achieve hemostasis post-Aquablation procedure.
Experimental: Catheter with Hemostatic Agent Following Aquablation AQUABEAM System followed by catheter with hemostatic agent	Device: AQUABEAM System followed by catheter with hemostatic agent The AquaBeam system delivers a high-pressure 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 physician will use balloon catheter with hemostatic agent to achieve hemostasis post-Aquablation procedure.

Arm

Intervention/Treatment

Experimental: Catheter without Hemostatic Agent Following Aquablation

AQUABEAM System followed by catheter without hemostatic agent

Device: AQUABEAM System followed by catheter without hemostatic agent

The AquaBeam system delivers a high-pressure 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 physician will use balloon catheter to achieve hemostasis post-Aquablation procedure.

Experimental: Catheter with Hemostatic Agent Following Aquablation

AQUABEAM System followed by catheter with hemostatic agent

Device: AQUABEAM System followed by catheter with hemostatic agent

Outcome Measures

Primary Outcome Measures

Number of subjects that do not require a transfusion and do not return to the operating room for hematuria management within 7 days following the index procedure. [7 days post-op]
Adequate hemostasis post-Aquablation with the use of a urinary catheter and / or delivery of a hemostatic agent, measured by the number of subjects that, within 7 days following the index procedure, do not require a transfusion and do not return to the operating room for hematuria management.