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)

NCT05213702 | Unknown DMC

• 1 other identifier: NDR-CT0023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Radiation exposure to patient and surgeon

  Day 0 surgery

• Assessment of AEs

  Admission day till discharge within 7 days

Study Arms (2)

Traditional free hand puncture for renal calyx access

ACTIVE COMPARATOR

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

RObotic ANT-X device puncture for renal calyx access

ACTIVE COMPARATOR

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

Interventions

Renal Calyx punture with traditional free hand or ANT-X device 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; Traditional free hand puncture for renal calyx access

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead
• NDR Medical Technology Pte Ltd: collaborator

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• WS Yeoh, MD

  UMMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WS Yeoh, MD

CONTACT

+60379494499; yeoh_uro@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Male/non-pregnant female subjects between age 18-75 years, both inclusive, who will undergo Percutaneous Nephrolithotomy (PCNL).

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: January 25, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share