NCT05213702

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)

A Randomized Controlled Trial 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) Performed by Urologists in Training.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Objectives: This study aims to determine if the device provides an advantage over traditional free hand puncture by comparing the number of attempts required to obtain access, time to achieve access, radiation exposure to patient and surgeon; and complications.

Detailed description

This is a single centre, participant randomized, open label study to evaluate the efficacy and safety of automated needle targeting (ANT-X) system compared to traditional free hand puncture for achieving renal access in Percutaneous lithotomy (PCNL) performed by urologists in training. Prior to performing kidney puncture on patients, all participating surgeons will undergo a simulation using Medical Simulation 12 balls phantom device with and without use of the ANT-X. Four urologic trainees (with similar little previous PCNL experience) will be recruited for the simulation. Two end points will be assessed: Number of attempts to achieve desired renal puncture and total fluoroscopy time. This simulation via 12 balls phantom device will involve fluoroscopic screening of calyx and successful puncture by urologic trainees under consultant supervision. Trainees will have 30 attempts of free hand puncture and 30 attempts using the ANT-X. The trainee will only move on to patient's renal puncture once they are able to achieve more than 80% of satisfactory renal puncture on simulator. For human renal puncture, we will aim for 60 cases of PCNL, 30 to be done using ANT-X puncture and 30 using traditional free hand puncture performed by 4 urologic trainees (15 cases per urologic trainee).

Conditions

• Kidney Stone

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-01-28
• Last updated: 2022-01-28