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)

NCT ID: NCT05213702

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NDR Medical Technology Pte Ltd

INDUSTRY

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yeoh Wei Sien

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

WS Yeoh, MD

Role: PRINCIPAL_INVESTIGATOR

UMMC

Central Contacts

WS Yeoh, MD

Role: CONTACT

yeoh_uro@yahoo.com

+60379494499 ext. 2981

Other Identifiers

NDR-CT0023

Identifier Type: -

Identifier Source: org_study_id