Clinical Trials Logo

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

NCT number NCT05213702
Study type Interventional
Source University of Malaya
Contact WS Yeoh, MD
Phone +60379494499
Status Not yet recruiting
Phase N/A
Start date January 25, 2022
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04495699 - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Recruiting NCT04559321 - Holmium Vs Trilogy Kidney Stones GUY's 1-2 Phase 3
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT06138327 - A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria Phase 1
Completed NCT03872843 - Opioid Free Management After Ureteroscopy Phase 4
Recruiting NCT04997668 - Clinical Outcomes and Healthcare Economics of SOLTIVE Compared to Ho:YAG Laser in Urolithiasis N/A
Active, not recruiting NCT04333745 - Influence of Obesity on Oxalate Metabolism and Handling in Calcium Oxalate Stone Formers N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Recruiting NCT04389853 - Mini-PNCL vs fURS in Management of Nephrolithiasis N/A
Recruiting NCT05334979 - Oxalate and Citrate N/A
Recruiting NCT05591716 - Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy. N/A
Recruiting NCT06209931 - RIRS With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini PCNLfor Kidney Stones
Withdrawn NCT04545528 - The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
Completed NCT05714423 - Outcomes in Lower Pole Kidney Stone Management Using Mini-PCNL Compared With Retrograde Intra Renal Surgery N/A
Recruiting NCT03281928 - Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling N/A
Recruiting NCT04835922 - Comparison of Efficacy of Intercostal Nerve Block vs Peritract Infiltration With 0.25% Bupivacaine in PCNL N/A
Recruiting NCT03257306 - Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS) N/A
Not yet recruiting NCT05504512 - Percutaneous Nephroscopic Treatment of Parapelvic Cysts
Recruiting NCT06306222 - Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease N/A
Not yet recruiting NCT04606758 - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease N/A