Robotic-assisted Percutaneous Access

NCT04435132 | Completed

• 1 other identifier: NDR-RA-PA-MY
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone

Keywords

PCNL; Percutaneous nephrolithotomy

Outcome Measures

Primary Outcomes (6)

• Needle insertion time

  Time taken for PCNL procedure

  During procedure

• Needle alignment time

  Time taken for needle alignment

  During procedure

• Time to target

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

  During procedure

• Number of needle insertion attempts to obtain access

  Number of attempts before successfully reaching the calyx

  During procedure

• Radiation dosage from placement of robot to efflux of urine

  A measure of the radiation exposed during the surgical procedure

  During procedure

• 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

Study Arms (1)

PCNL with the aid of the robotic device

EXPERIMENTAL

Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device.

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

Interventions

PCL under fluoroscopy with the aid of the robotic device 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.

PCNL with the aid of the robotic device

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NDR Medical Technology Pte Ltd: lead
• University of Malaya: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 19057227 BACKGROUND

• 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.

  PMID: 21981795 BACKGROUND

• 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.

  PMID: 29699415 RESULT

Related Links

• Urologic robots and future directions
• How today's robots work and perspectives for the future. J Visc Surg. 2011

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device. They will then be admitted to inpatient ward as per standard of care for PCNL.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 17, 2020
• Study Start: August 7, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)