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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)

Primary Purpose

Kidney Stone

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Traditional free hand puncture for renal calyx access

RObotic ANT-X device puncture for renal calyx access

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Radiation exposure to patient and surgeon

Assessment of AEs

Advere events associated with the procedure

Full Information

NCT ID

NCT05213702

First Posted

January 16, 2022

Last Updated

January 16, 2022

Sponsor

University of Malaya

Collaborators

NDR Medical Technology Pte Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05213702

Brief Title

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)

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 25, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Malaya

Collaborators

NDR Medical Technology Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Stone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Traditional free hand puncture for renal calyx access

Arm Type

Active Comparator

Arm Description

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).

Arm Title

RObotic ANT-X device puncture for renal calyx access

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of attempts required to obtain access

Description

An access attempt is defined as each separate passage of the needle into the kidney. Number of attempts by Investigator/surgeon will be recorded.

Time Frame

Day 0 surgery

Title

Time for the access

Description

Time Frame

Day 0 surgery

Secondary Outcome Measure Information:

Title

Radiation exposure to patient and surgeon

Time Frame

Day 0 surgery

Title

Assessment of AEs

Description

Advere events associated with the procedure

Time Frame

Admission day till discharge within 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

WS Yeoh, MD

Phone

+60379494499

Ext

2981

yeoh_uro@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

WS Yeoh, MD

Organizational Affiliation

UMMC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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)

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