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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)

Kidney Stone Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05213702
Study type Interventional
Source University of Malaya
Contact WS Yeoh, MD
Phone +60379494499
Email yeoh_uro@yahoo.com
Status Not yet recruiting
Phase N/A
Start date January 25, 2022
Completion date December 31, 2022
View Details
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