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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Device: Renal Calyx punture with traditional free hand or ANT-X device

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WS Yeoh, MD; Phone Number: 2981 +60379494499; Email: yeoh_uro@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects willing to sign informed consent form before initiation of any study specific procedures.
• Subjects diagnosed with kidney stones and planned for prone PCNL.
• Male/ non- pregnant female subjects between 18-75 years (both inclusive) of age at the time of informed consent.
• Subjects with renal stones of ≥1 cm or not managed by other stone treatments (e.g. shock wave lithotripsy, ureteroscopy).
• Serum creatinine of < 1.2 mg/dl.

Exclusion Criteria:

• Subjects with bleeding disorders.
• Recent infection of the kidney or urinary tract which leads to pus accumulation in the kidney, i.e., Pyonephrosis.
• Subjects not able to have prone positions for surgical procedure due to comorbid conditions.
• Renal stones < 1 cm and can managed by another technique.
• Patients with moderate to severe renal failure.
• Patients with congenital urinary tract anomalies.
• Patients on anticoagulation or antiplatelet therapy.
• Evidence or history of any other disease that in the opinion of the investigator would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
• Legal incapacity or other circumstances that render the subject unable to understand the nature, scope and possible consequences of the study.
• Clinically significant abnormal findings or condition (other than kidney stone), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional free hand puncture for renal calyx access; For human PCNL, we target 60 cases of PCNL, 30 ANT-X puncture and 30 traditional free hand puncture performed by 4 urologic trainees(15 cases per urologic trainee).	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
ACTIVE_COMPARATOR: RObotic ANT-X device puncture for renal calyx access; For human PCNL, we target 60 cases of PCNL, 30 ANT-X puncture and 30 traditional free hand puncture performed by 4 urologic trainees(15 cases per urologic trainee).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts required to obtain access	An access attempt is defined as each separate passage of the needle into the kidney. Number of attempts by Investigator/surgeon will be recorded.	Day 0 surgery
Time for the access	Time to successful access into the collecting system will be calculated in minutes starting from the placement of the needle on the skin surface to the identification of urine efflux from the end of the needle or reach of target. Start time of needle placement and time of urine efflux from the end of the needle or reach of target will be recorded in subject CRF in hh:mm:ss format.	Day 0 surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation exposure to patient and surgeon		Day 0 surgery
Assessment of AEs	Advere events associated with the procedure	Admission day till discharge within 7 days

Collaborators and Investigators

• Sponsor: University of Malaya
• Collaborators: NDR Medical Technology Pte Ltd
• Investigators: Principal Investigator: WS Yeoh, MD, UMMC

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 25, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: NDR-CT0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No