AQUABEAM® Robotic System and Ultrasound Accessories

Summary

Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 25% (Hunter et al. 1994). The complaints are potentially associated with a considerable impairment of the quality of life (Trueman et al. 1999). LUTS in older men are commonly caused by a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE). The histological term "benign prostatic hyperplasia" (BPH) is frequently used in literature and clinical practice as a synonym for this diagnosis.

Surgical therapy of BPH has continuously evolved in recent years. One of the latest technologies for transurethral prostate desobstruction is the Aquablation therapy, first described in 2015 (AQUABEAM®, PROCEPT BioRobotics, Redwood Shores, CA, USA) (Faber et al 2015). The AQUABEAM Robotic System is the first and only image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is designed for cutting of prostate tissue during a minimally invasive surgical procedure. Once inserted via a transurethral approach and advanced through the urethra and into the prostatic urethra, the device applies an ultrasound-guided water jet that precisely ablates the prostate tissue. Aquablation therapy is unique in that it combines cystoscopic visualization, ultrasound imaging and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. This enables personalized treatment planning for the patient's unique anatomy, improved decisionmaking and real-time monitoring during the procedure.

This prospective single-arm investigational clinical trial aims at assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System and compare the percentage of patients who are discharged the day of the surgery among different groups of BPH patients who undergo aquablation using the third generation of the AQUABEAM Robotic System.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

DEVICE

AQUABEAM Robotic System

The AQUABEAM Robotic System is developed and manufactured by PROCEPT BioRobotics, Corp. It is intended for use in patients suffering from lower urinary tract (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for cutting of prostate tissue during minimally invasive surgical procedure and shall be inserted via transurethral approach and is advanced through the urethra and into the prostatic urethra. The system is designed to utilize a high-velocity sterile saline stream as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a high-velocity pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on a medical panel computer. Pre-condition parameters are set on the console before operation.

DEVICE

Apogee 2300 digital color doppler ultrasound imaging system

The SIUI Apogee 2300 is a digital ultrasound imaging system capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

Sponsors & Collaborators

• PROCEPT BioRobotics

  collaborator INDUSTRY

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Principal Investigators

• Naeem Bhojani, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-16

Primary Completion

2024-04-15

Completion

2024-12-30

FDA Device

Yes

Countries

• Canada

Study Locations