Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LARC Robotic System (Micromateâ„¢ Version 3.0) | Device | The LARC Robotic System (Version 3.0) is an investigational configuration of the Micromateâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss (EBL) | Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods. | During procedure (Day 0) |
| Operative Time | Total time (in minutes) from skin incision to procedure completion. Sub-analysis includes time from renal access start to access success. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advent Health Medical Group Urology at Celebration | Celebration | Florida | 34747 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 37458736 | 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. | |
| 34582338 |
Not provided
Not provided
We will not be sharing information from this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| During procedure (Day 0) |
| Radiation Exposure | Total fluoroscopy time and radiation dose (in mGy and seconds) recorded during robotic-assisted access using the LARC system. | During procedure (Day 0) |
| Postoperative Complications | All adverse events will be recorded and graded using the Clavien-Dindo classification system. Includes infection, transfusion, organ injury, and reintervention. | Up to 30 days post-procedure |
| Number of Access Attempts | Number of needle punctures required to achieve access to the renal collecting system. | During procedure (Day 0) |
| 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. |
| 26816715 | 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. |
| 21247286 | 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. |
| 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 |
| 36136905 | 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. |
| 28220589 | 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. |
| 28859496 | 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. |
| 30039711 | 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. |
| 33430693 | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |