A RCT to Evaluate the Efficacy and Safety of Automated Needle Targeting (ANT-X) System Compared to Traditional Free Hand Puncture for Renal Access in Percutaneous Nephrolithotomy (PCNL)

NAUnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
Kidney Stone
Interventions
DEVICE

Renal Calyx punture with traditional free hand or ANT-X device

ANT-X device is a software-controlled automated electromechanical arm. It is developed to provide needle guidance for surgeon in MIS. This aims to reduce the surgery time taken and also minimize the radiation withstand by both surgeon and patient. ANT-X device is actually a Delta parallel robot implementing inverse kinematics to achieve effector's movement. Parallel structures excel in their great stiffness and high positioning accuracy. Most of the main components of ANT-X robot are made up of medical grade Polyether ether ketone (PEEK) material. PEEK is preferred to build the robot because it is radiolucent and lightweight while being able to provide relatively high material strength. The device is intended for use together with C-arm fluoroscope (fluoroscopy/CT technology). The fluoroscopy technology is used to provide image guidance for the needle

Sponsors
All Listed Sponsors
collaborator

NDR Medical Technology Pte Ltd

INDUSTRY

lead

University of Malaya

OTHER