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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: AquaBeam System


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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Subjects will receive treatment with the AquaBeam System to remove prostatic tissue. | Device: AquaBeam System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 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