Clinical trial NCT04435132: Robotic-assisted Percutaneous Access
Official title: Robotic-assisted Percutaneous Access: Interventional, Non-randomized, Open-label, Non-comparative and First-in-Man Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: PCNL
Percutaneous nephrolithotomy
Lead sponsor: NDR Medical Technology Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Malaya
First posted: 2020-06-17
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Needle insertion time
timeFrame: During procedure
measure: Needle alignment time
timeFrame: During procedure
measure: Time to target
timeFrame: During procedure
measure: Number of needle insertion attempts to obtain access
timeFrame: During procedure
measure: Radiation dosage from placement of robot to efflux of urine
timeFrame: During procedure
measure: Radiation dosage from placement of robot to successful needle target via image confirmation
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.