Renal Stone DiseaseNCT07211555
The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy
A study testing LARC Robotic System (Micromate™ Version 3.0) in people with Renal Stone Disease and Kidney Calculi, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone Disease, Kidney Calculi, Refractory Kidney Stones
- What is being tested?
- LARC Robotic System (Micromate™ Version 3.0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Petronio Senior Clinical Research Operations Manager, MHA contact
Bridget Clinical Research Operations Manager, MS, MPH contact
United States1 site
Advent Health Medical Group Urology at Celebration
Celebration, Florida, 34747
Petronio Martins, MHA, 407-303-3603, petronio.martins@adventhealth.com
Bridget Miller, MS, MPH, 407-303-3603, bridget.miller@adventhealth.com
About this study
Official title: The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)
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.
Read more
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.
- Being tested
- LARC Robotic System (Micromate™ Version 3.0)
- Keywords
- Robotic Surgery, Minimally Invasive Surgery
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LARC Robotic System (Micromate™ Version 3.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: During procedure (Day 0)
Secondary outcomes (5)
Estimated Blood Loss (EBL)
Volume of blood loss (in mL) recorded during PCNL using the LARC system, measured via standard intraoperative methods.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days post-procedure
Number of Access Attempts
Number of needle punctures required to achieve access to the renal collecting system.
Measured: During procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Renal Stone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211555
- Sponsor's protocol ID
- 2196760
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will not be sharing information from this study.
Publications
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.
PubMed 37458736Saluk 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.
PubMed 34582338Taylor 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.
PubMed 26816715de 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.
PubMed 21247286Korets 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.
PubMed 36136905Armitage 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.
PubMed 28220589Speed 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.
PubMed 28859496Quirke 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.
PubMed 30039711Metzler 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.
PubMed 33430693
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT07211555
- Acronym / sponsor ID
- 2196760
- Keywords
- Robotic Surgery, Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assisted PCNL Using LARC System | Experimental | Device: LARC Robotic System (Micromate™ Version 3.0)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Assisted PCNL Using LARC System |
Primary outcome
Stone-Free Rate (SFR)
Time frame: Within 30 days post-procedure
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).
Procedure Success Rate
Time frame: During procedure (Day 0)
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.
5 secondary outcomes
Estimated Blood Loss (EBL)
Time frame: During procedure (Day 0)
Operative Time
Time frame: During procedure (Day 0)
Radiation Exposure
Time frame: During procedure (Day 0)
Postoperative Complications
Time frame: Up to 30 days post-procedure
Number of Access Attempts
Time frame: During procedure (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- BackgroundEscobar 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: PubMed 37458736Nguyen 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.
- Background: PubMed 34582338Saluk 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.
- Background: PubMed 26816715Taylor 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.
- Background: PubMed 21247286de 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.
- BackgroundKorets 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: PubMed 36136905Ghoulian 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.
- Background: PubMed 28220589Armitage 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.
- Background: PubMed 28859496Speed 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.
- Background: PubMed 30039711Quirke 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.
- Background: PubMed 33430693Metzler 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.
- Individual participant dataSharing planned: No. We will not be sharing information from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petronio Senior Clinical Research Operations Manager, MHA contact
Bridget Clinical Research Operations Manager, MS, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARC Robotic System (Micromate™ Version 3.0) in people with Renal Stone Disease and Kidney Calculi, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petronio Senior Clinical Research Operations Manager, MHA (407-303-3603, Petronio.martins@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: Within 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211555, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.