Robotic-assisted Percutaneous Access

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435132
• Other study ID #: NDR-RA-PA-MY
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2020
• Source: NDR Medical Technology Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Device:
• PCL under fluoroscopy with the aid of the robotic device
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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
NDR Medical Technology Pte Ltd	University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

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. Review. Erratum in: J Visc Surg. 2012 Feb;149(1):e81. — View 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. Review. — View 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. 2018 Apr 27. doi: 10.1089/end.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle insertion time	Time taken for PCNL procedure	During procedure
Primary	Needle alignment time	Time taken for needle alignment	During procedure
Primary	Time to target	Time taken for the needle to reach the calyx, from on the skin to successful needle targeting	During procedure
Primary	Number of needle insertion attempts to obtain access	Number of attempts before successfully reaching the calyx	During procedure
Primary	Radiation dosage from placement of robot to efflux of urine	A measure of the radiation exposed during the surgical procedure	During procedure
Primary	Radiation dosage from placement of robot to successful needle target via image confirmation	A measure of the radiation exposed during the surgical procedure	During procedure

External Links

•   Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol 2018 Apr 27
•   How today's robots work and perspectives for the future. J Visc Surg. 2011
•   Urologic robots and future directions