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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: AQUABEAM System followed by catheter without hemostatic agent
* Device: AQUABEAM System followed by catheter with hemostatic agent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male BPH symptoms Exclusion Criteria: Serious concurrent medical conditions

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter without Hemostatic Agent Following Aquablation<br>AQUABEAM System followed by catheter without hemostatic agent | Device: AQUABEAM System followed by catheter without hemostatic agent<br>* 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.<br>|
| Experimental: Catheter with Hemostatic Agent Following Aquablation<br>AQUABEAM System followed by catheter with hemostatic agent | Device: AQUABEAM System followed by catheter with hemostatic agent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 7 days post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Image-guided, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics