Kidney StoneNCT05213702
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 study testing Renal Calyx punture with traditional free hand or ANT-X device in people with Kidney Stone, run by University of Malaya.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Renal Calyx punture with traditional free hand or ANT-X device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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
- Being tested
- Renal Calyx punture with traditional free hand or ANT-X device
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Calyx punture with traditional free hand or ANT-X deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Renal Calyx punture with traditional free hand or ANT-X device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 surgery
Secondary outcomes (2)
Radiation exposure to patient and surgeon
Measured: Day 0 surgery
Assessment of AEs
Advere events associated with the procedure
Measured: Admission day till discharge within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start25 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Male/non-pregnant female subjects between age 18-75 years, both inclusive, who will undergo Percutaneous Nephrolithotomy (PCNL).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- NDR Medical Technology Pte Ltd
- Responsible party
- Principal investigator, Dr. Yeoh Wei Sien, University of Malaya
- Investigators
- WS Yeoh, MD, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213702
- Sponsor's protocol ID
- NDR-CT0023
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05213702
- Acronym / sponsor ID
- NDR-CT0023
- Conditions
- Kidney Stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- NDR Medical Technology Pte Ltd
- Study start
- 25 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Male/non-pregnant female subjects between age 18-75 years, both inclusive, who will undergo Percutaneous Nephrolithotomy (PCNL).
| Arm | Type | Receives |
|---|---|---|
| Traditional free hand puncture for renal calyx access | Active comparator | Device: Renal Calyx punture with traditional free hand or ANT-X deviceFor 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). |
| RObotic ANT-X device puncture for renal calyx access | Active comparator | Device: Renal Calyx punture with traditional free hand or ANT-X deviceFor 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal Calyx punture with traditional free hand or ANT-X deviceANT-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 | Device | RObotic ANT-X device puncture for renal calyx access, Traditional free hand puncture for renal calyx access |
Primary outcome
Number of attempts required to obtain access
Time frame: Day 0 surgery
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 frame: Day 0 surgery
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.
2 secondary outcomes
Radiation exposure to patient and surgeon
Time frame: Day 0 surgery
Assessment of AEs
Time frame: Admission day till discharge within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WS Yeoh, MD principal investigator
UMMC
Questions about this trial
What is this clinical trial studying?
A study testing Renal Calyx punture with traditional free hand or ANT-X device in people with Kidney Stone, run by University of Malaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WS Yeoh, MD (+60379494499 ext. 2981, yeoh_uro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempts required to obtain access (time frame: Day 0 surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.