The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

NCT07211555 | Not Yet Recruiting FDA Device

• 1 other identifier: 2196760
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove large kidney stones. The procedure, called percutaneous nephrolithotomy (PCNL), is typically used for people who have large or difficult-to-remove kidney stones. Traditionally, many urologists rely on radiologists to place a tube into the kidney before surgery. This can cause delays, require multiple procedures, and increase costs. The robotic system being studied - called LARC - is designed to help the urologist safely and accurately guide a needle directly into the kidney during the surgery, without needing a separate procedure beforehand. The robot uses live X-ray images to help align the instruments. Although parts of the robot have been approved by the U.S. FDA, the version used in this study is still investigational and not yet approved for this specific purpose. The study will take place at AdventHealth Celebration and include up to 45 adult patients who are scheduled for PCNL surgery. Participants will be followed for up to 1 month after surgery, and doctors will look at outcomes such as the success of the procedure, the number of kidney stones removed, complications, time in surgery, and radiation exposure. This research may help make kidney stone surgery safer, faster, and more effective in the future.

Conditions

Renal Stone Disease; Kidney Calculi; Refractory Kidney Stones; Kidney Stones

Keywords

Robotic Surgery; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (2)

• Stone-Free Rate (SFR)

  Proportion of participants with no residual kidney stones larger than 4 mm, as determined by imaging (non-contrast CT, KUB X-ray, or renal ultrasound).

  Within 30 days post-procedure

• Procedure Success Rate

  Proportion of procedures in which the urologist was able to successfully obtain renal access and complete the PCNL using the LARC robotic system, without converting to manual or radiologist-assisted access.

  During procedure (Day 0)

Secondary Outcomes (5)

• Estimated Blood Loss (EBL)

  During procedure (Day 0)

• Operative Time

  During procedure (Day 0)

• Radiation Exposure

  During procedure (Day 0)

• Postoperative Complications

  Up to 30 days post-procedure

• Number of Access Attempts

  During procedure (Day 0)

Study Arms (1)

Assisted PCNL Using LARC System

EXPERIMENTAL

This arm includes participants who will undergo percutaneous nephrolithotomy (PCNL) with renal access guided by the investigational LARC robotic system (Version 3.0). The procedure uses fluoroscopy-based navigation to assist the urologist in targeting the renal collecting system.

Device: LARC Robotic System (Micromate™ Version 3.0)

Interventions

LARC Robotic System (Micromate™ Version 3.0) DEVICE

The LARC Robotic System (Version 3.0) is an investigational configuration of the Micromate™ robotic platform by iSYS Medizintechnik GmbH (Austria). It uses fluoroscopy-based surgical navigation to assist urologists in obtaining precise renal access during percutaneous nephrolithotomy (PCNL). This version is not FDA-cleared and is being evaluated for feasibility, safety, and potential clinical benefit.

Assisted PCNL Using LARC System

Eligibility Criteria

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

You may qualify if:

• Kidney stones larger than 2 cm
• Staghorn renal calculi
• Lower pole stones less than 2 cm
• Anatomical abnormalities that reduce the likelihood of spontaneous stone fragment passage, such as:
• Horseshoe kidney
• Calyceal diverticulum
• Ectopic or dystopic kidney
• Stones that are refractory to prior treatment (e.g., ESWL or ureteroscopy)
• Suspected malignant tumors or masses located in the planned renal access tract

You may not qualify if:

• Pregnancy
• Active urinary tract infection (UTI) or untreated sepsis
• Known bleeding disorders or uncorrectable coagulopathy despite medical management
• Use of anticoagulant medications (e.g., warfarin, heparin, or DOACs) that cannot be safely discontinued
• Allergy to contrast media that cannot be pre-medicated or managed
• Severe cardiopulmonary comorbidities that contraindicate anesthesia or PCNL
• Inability to provide informed consent
• Participation in another investigational study that may interfere with study outcomes

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Advent Health Medical Group Urology at Celebration

Celebration, Florida, 34747, United States

Location

Related Publications (11)

• Escobar Monroy R, Proietti S, De Leonardis F, Gisone S, Scalia R, Mongelli L, Gaboardi F, Giusti G. Complications in Percutaneous Nephrolithotomy. Complications. 2025; 2(1):5. https://doi.org/10.3390/complications2010005

  BACKGROUND

• Nguyen MV, Berger JH, Flores AR, Chen TT, Yared J, Pais V, Chew B, Humphreys MR, Stern KL, Sur RL. Case series - Liver injury during percutaneous nephrolithotomy. Can Urol Assoc J. 2023 Sep;17(9):E297-E301. doi: 10.5489/cuaj.8291. No abstract available.

  PMID: 37458736 BACKGROUND

• Saluk J, Ebel J, Rose J, Posid T, Sourial M, Knudsen B. Fellowship training in endourology: Impact on percutaneous nephrolithotomy access patterns. Can Urol Assoc J. 2022 Feb;16(2):E76-E81. doi: 10.5489/cuaj.7339.

  PMID: 34582338 BACKGROUND

• Taylor E, Miller J, Chi T, Stoller ML. Complications associated with percutaneous nephrolithotomy. Transl Androl Urol. 2012 Dec;1(4):223-8. doi: 10.3978/j.issn.2223-4683.2012.12.01. No abstract available.

  PMID: 26816715 BACKGROUND

• de la Rosette J, Assimos D, Desai M, Gutierrez J, Lingeman J, Scarpa R, Tefekli A; CROES PCNL Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. J Endourol. 2011 Jan;25(1):11-7. doi: 10.1089/end.2010.0424.

  PMID: 21247286 BACKGROUND

• Korets R, Speed JM, Wang Y, Chang SL. PD21-03 Percutaneous Access Obtained By Urologist Is Associated With Decreased Complications, Shorter Length Of Stay, And Lower Hospital Costs In PCNL. J Urol. 2017;197(4S):e436-e437. doi:10.1016/j.juro.2017.02.1041

  BACKGROUND

• Ghoulian J, Nourian A, Dalimov Z, Ghiraldi EM, Friedlander JI. Percutaneous Nephrolithotomy Access: A Meta-Analysis Comparing Access by Urologist vs Radiologist. J Endourol. 2023 Jan;37(1):8-14. doi: 10.1089/end.2022.0308. Epub 2022 Nov 14.

  PMID: 36136905 BACKGROUND

• Armitage JN, Withington J, Fowler S, Finch WJG, Burgess NA, Irving SO, Glass J, Wiseman OJ; BAUS section of Endourology. Percutaneous nephrolithotomy access by urologist or interventional radiologist: practice and outcomes in the UK. BJU Int. 2017 Jun;119(6):913-918. doi: 10.1111/bju.13817. Epub 2017 Mar 21.

  PMID: 28220589 BACKGROUND

• Speed JM, Wang Y, Leow JJ, Bhojani N, Trinh QD, Chang SL, Korets R. The Effect of Physician Specialty Obtaining Access for Percutaneous Nephrolithotomy on Perioperative Costs and Outcomes. J Endourol. 2017 Nov;31(11):1152-1156. doi: 10.1089/end.2017.0441. Epub 2017 Oct 4.

  PMID: 28859496 BACKGROUND

• Quirke K, Aydin A, Brunckhorst O, Bultitude M, Khan MS, Dasgupta P, Sarica K, Ahmed K. Learning Curves in Urolithiasis Surgery: A Systematic Review. J Endourol. 2018 Nov;32(11):1008-1020. doi: 10.1089/end.2018.0425.

  PMID: 30039711 BACKGROUND

• Metzler IS, Holt S, Harper JD. Surgical Trends in Nephrolithiasis: Increasing De Novo Renal Access by Urologists for Percutaneous Nephrolithotomy. J Endourol. 2021 Jun;35(6):769-774. doi: 10.1089/end.2020.0888. Epub 2021 Apr 5.

  PMID: 33430693 BACKGROUND

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

Central Study Contacts

Petronio Senior Clinical Research Operations Manager, MHA

CONTACT

407-303-3603; Petronio.martins@adventhealth.com

Bridget Clinical Research Operations Manager, MS, MPH

CONTACT

407-303-3603; Bridget.Miller@adventhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: October 8, 2025
• Study Start: November 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)