AQUABEAM® Robotic System and Ultrasound Accessories

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 16, 2023

Primary Completion Date

April 15, 2024

Study Completion Date

December 30, 2024

Conditions
Benign Prostatic HyperplasiaLower 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."

Trial Locations (1)

QC H2X 0A9

RECRUITING

Centre Hospitalier de l'université de Montréal (CHUM), Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PROCEPT BioRobotics

INDUSTRY

lead

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

NCT05157529 - AQUABEAM® Robotic System and Ultrasound Accessories | Biotech Hunter | Biotech Hunter