The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

Официальное название

The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)

Обзор

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.

Вмешательства

• Устройство LARC Robotic System (Micromate™ Version 3.0)
  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.

Первичные конечные точки

• Stone-Free Rate (SFR) [Срок оценки: Within 30 days post-procedure]
• Procedure Success Rate [Срок оценки: During procedure (Day 0)]

Вторичные конечные точки (5)

• Estimated Blood Loss (EBL) [Срок оценки: During procedure (Day 0)]
• Operative Time [Срок оценки: During procedure (Day 0)]
• Radiation Exposure [Срок оценки: During procedure (Day 0)]
• Postoperative Complications [Срок оценки: Up to 30 days post-procedure]
• Number of Access Attempts [Срок оценки: During procedure (Day 0)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Advent Health Medical Group Urology at Celebration — Celebration

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07211555 · 2196760

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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