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Kidney StoneNCT04435132

Robotic-assisted Percutaneous Access

A study testing PCL under fluoroscopy with the aid of the robotic device in people with Kidney Stone, run by NDR Medical Technology Pte Ltd at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a first-in-man (FIM) study to show feasibility and safety profile of the newly developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone disease who had standard indications for prone PCNL were included in the study. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Kidney Stone
What is being tested?
PCL under fluoroscopy with the aid of the robotic device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteMalaysia
Study dates
7 Aug 2018to 1 Nov 2018
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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 21 to 75 years
  • Diagnosed with kidney stone disease and planned for prone PCNL with indication for surgery as per standard of care
  • Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Who cannot join

  • Bleeding disorders
  • Patient on anticoagulation/antiplatelets drugs
  • Pyonephrosis
  • Pregnant women
  • Not able to have prone position for the procedure due to comorbidities
  • Moderate to severe renal failure
  • The patient's life expectancy is less than 12 months
  • Poor compliance and patients unable to complete the study in accordance with the requirements.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

About this study

Official title: Robotic-assisted Percutaneous Access: Interventional, Non-randomized, Open-label, Non-comparative and First-in-Man Study

This is a first-in-man (FIM) study to show feasibility and safety profile of the newly developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone disease who had standard indications for prone PCNL were included in the study. PCNL was conducted with percutaneous puncture with the aid of robotic device with the use of intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3 months. Punctures were performed by the board-qualified urologist.

Read the detailed description

All patients underwent preoperative investigations and imaging study (CT Urogram/Intravenous Pyelography) done prior to the operation as per standard operation preparation. Intraoperatively fluoroscopic imaging was done for the patients and the images were synchronized to the software. Robotic arm was placed on the site of surgery as for prone PCNL and diaphragm of the arm was centred over the site of desire calyx of entry. A needle was engaged into the centre of the diaphragm and using the software the need was aligned in the line of puncture automatically based on the fluoroscopic images. After the alignment was done the needle was advanced manually by the surgeon until the entry was confirmed by efflux of urine from the puncture needle. After the entry was confirmed a standard PCNL using 24 F or 30 F Balloon dilator was performed and stone cleared using Cyberwand/ Shockpulse etc. All the intraoperative and perioperative parameters as mentioned in the data collection form was measured. Results was analysed with the main focus on time of obtaining the puncture, accuracy of puncture, radiation exposure time till calyceal entry which was confirmed by free flow of urine and for any complications.

Patients aged between 21 to 75 years old who were diagnosed with kidney stone diseas and planned for prone PCNL with indication for surgery as per standard of care were recruited. They understood the purpose of testing and offered their voluntary and informed consent.

The robotic device i.e. ANT lesses the learning curve of percutaneous access as it reduces the need for surgeon's visualization of the calyceal system and the needle alignment. It also improved efficiency as there is less dependence on human skills during the procedure. As a whole, the FIM trial was a success. The performance of the ANT system during the trial was satisfactory. The robot alignment time is less than 30 seconds. Total puncture time was around 6 minutes and no AEs were reported.

Conditions
Kidney Stone
Being tested
PCL under fluoroscopy with the aid of the robotic device
Keywords
PCNL, Percutaneous nephrolithotomy
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCL under fluoroscopy with the aid of the robotic deviceDevice

    During the surgery, the robot was positioned over the estimated insertion point. It was aligned to be parallel to the fluoroscope imaging plane as much as possible. The needle is to be placed through the holder, and slightly penetrate the surface of the skin. An x-ray image is then taken to ensure that the whole device can be seen on the screen. Image calibration is then performed through the software GUI. After which, the clinician is also to perform needle tip selection. After which, needle alignment will then be performed. Once needle alignment is complete, the clinician will then advance the trocar needle into the patient's body, using the fluoroscopy to judge the penetration depth. Once the target has been reached, the needle style is to be extracted. The indication of leakage of fluid through the outer needle confirms the success of the procedure.

Study groups in NCT04435132
Study groupRoleWhat they receive
PCNL with the aid of the robotic deviceExperimentalPatients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device.
Receives: Device: PCL under fluoroscopy with the aid of the robotic device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Needle insertion time

    Time taken for PCNL procedure

    Measured: During procedure

  2. Needle alignment time

    Time taken for needle alignment

    Measured: During procedure

  3. Time to target

    Time taken for the needle to reach the calyx, from on the skin to successful needle targeting

    Measured: During procedure

  4. Number of needle insertion attempts to obtain access

    Number of attempts before successfully reaching the calyx

    Measured: During procedure

  5. Radiation dosage from placement of robot to efflux of urine

    A measure of the radiation exposed during the surgical procedure

    Measured: During procedure

  6. Radiation dosage from placement of robot to successful needle target via image confirmation

    A measure of the radiation exposed during the surgical procedure

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2020
  2. Study start7 Aug 2018
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Recruitment was carried out in University Malaya Medical Centre (UMMC) Hospital clinics and impatient wards. 5 patients were recruited with no preferred selection for gender or race. Patients recruited were set to be between 21 to 75 years of age. Patients presenting to to clinic or admitted to ward for renal stone disease were assessed for indications of PCNL. Patients were assessed for renal stone disease as per standard of care - imaging study with CT scan, renal function, clinical assessment of fitness and suitability for prone PCNL. Once patients were planned for prone PCNL, they will be informed about this study, the use of robotic device, potential benefits and complications by study investigators. If they are agreeable to informed consent, they will be recruited into the study.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435132
Sponsor's protocol ID
NDR-RA-PA-MY
Status last verified
Jun 2020
First submitted
9 Jun 2020
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mozer P, Troccaz J, Stoianovici D. Urologic robots and future directions. Curr Opin Urol. 2009 Jan;19(1):114-9. doi: 10.1097/MOU.0b013e32831cc1ba.

    PubMed 19057227

  • Cinquin P. How today's robots work and perspectives for the future. J Visc Surg. 2011 Oct;148(5 Suppl):e12-8. doi: 10.1016/j.jviscsurg.2011.08.003. Epub 2011 Oct 5. No abstract available.

    PubMed 21981795

  • Oo MM, Gandhi HR, Chong KT, Goh JQ, Ng KW, Hein AT, Tan YK. Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol. 2021 Jun;35(6):e919. doi: 10.1089/end.2018.0003.

    PubMed 29699415

Questions about this trial

What is this clinical trial studying?

A study testing PCL under fluoroscopy with the aid of the robotic device in people with Kidney Stone, run by NDR Medical Technology Pte Ltd at 1 site in Malaysia.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Needle insertion time (time frame: During procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04435132, which also lists 3 linked publications.

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 17 Jun 2020.

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