Robotic Surgery for Kidney Stones

(STAR Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Margaret A. Knoedler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Auris Health, Inc.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Robotic Surgery for Kidney Stones is an effective treatment?

The available research shows that Robotic Surgery for Kidney Stones, specifically mini-percutaneous nephrolithotomy (mini-PCNL), is effective for treating kidney stones. One study compared mini-PCNL to another method called retrograde intrarenal surgery (RIRS) for stones larger than 10 mm and found that mini-PCNL was effective in a single session. Another study looked at stones between 1-2 cm and found that mini-PCNL had favorable outcomes in terms of operation time and hospital stay. Additionally, a study comparing mini-PCNL to standard PCNL for stones 2-4 cm showed that mini-PCNL was effective and safe. Overall, these studies suggest that mini-PCNL is a reliable treatment option for kidney stones.

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What safety data is available for robotic-assisted kidney stone surgery?

The safety data for robotic-assisted kidney stone surgery, evaluated under names like mini-PCNL and percutaneous nephrolithotomy, includes several studies. These studies assess the safety and efficacy of mini-PCNL in various contexts, such as treating large impacted ureteral stones, complex staghorn stones in children, and small renal stones in infants. The studies generally indicate that mini-PCNL is a safe and effective procedure with little morbidity, even in complex cases like staghorn calculi in a solitary kidney.

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Is Robotic-assisted mini-PCNL a promising treatment for kidney stones?

Yes, Robotic-assisted mini-PCNL is a promising treatment for kidney stones. It uses advanced technology to effectively manage kidney stones, especially larger ones, with minimal impact on the body. This method is well-regarded for its effectiveness and safety in treating kidney stones.

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Eligibility Criteria

This trial is for individuals with kidney stones. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.

Inclusion Criteria

Participants with a percutaneous tract length less than 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan

I am considered suitable for a mini-PCNL procedure as per my doctor's assessment.

I have kidney stones larger than 1 cm suitable for PCNL treatment.

Exclusion Criteria

Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.

Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results

I have stones stuck in my ureter.

Participant Groups

The STAR Study is testing a procedure called robotic-assisted mini-PCNL using the MONARCH Platform in Urology. It aims to evaluate how well the procedure works, its ability to clear kidney stones post-operation, and its safety.

Group I: Robotic mini-Percutaneous Nephrolithotomy (PCNL) Experimental Treatment 1 Intervention

Participants with kidney stones will be enrolled for a robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of kidney stones. The MONARCH Platform, Urology enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible mini-PCNL suction catheter ("catheter") for visualization and access to the urinary tract for diagnostic and therapeutic procedures.

Robotic-assisted mini-PCNL is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Robotic-assisted mini-PCNL for:

• Kidney stones
• Ureteral stones

🇪🇺 Approved in European Union as Robotic-assisted mini-PCNL for:

• Kidney stones
• Ureteral stones

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Wisconsin Madison, WI

Indiana University Bloomington, IN

UW School of Medicine and Public Health Madison, WI

Indiana University Indianapolis, IN

Who Is Running the Clinical Trial?

Auris Health, Inc. Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison among the available stone treatment techniques from the first European Association of Urology Section of Urolithiasis (EULIS) Survey: Do we have a Queen? [2019] The miniaturization of instruments has had an impact on stone management. The aims of this study were to highlight surgeon preferences among Retrograde Intra Renal Surgery (RIRS), Regular, Mini-, UltraMini- and Micro- Percutaneous Nephrolithotomy (PCNL) for urolithiasis and to compare the effectiveness and safety of these techniques in a real-life setting.

2. India pubmed.ncbi.nlm.nih.gov

Prospective study on Comparison of outcomes of mini percutaneous nephrolithotomy versus retrograde intrarenal surgery for renal stones of 1-2 cm size. [2022] The aim of this study is to demonstrate the outcomes of retrograde intrarenal surgery (RIRS) and Mini percutaneous nephrolithotomy (M-PCNL) in the management of 1-2 cm renal stones, with factors considered being operative time, duration of hospital stay, complication rate, and auxiliary procedure rate.

3. United States pubmed.ncbi.nlm.nih.gov

Mini-percutaneous Nephrolithotomy vs Retrograde Intrarenal Surgery for Renal Stones Larger Than 10 mm: A Prospective Randomized Controlled Trial. [2016] To compare miniaturized percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) in the management of renal stones >10 mm in a single session.

4. China pubmed.ncbi.nlm.nih.gov

[Mini-percutaneous nephrolithotomy in the treatment of un-hydronephrotic cata-staghorn renal calculi]. [2007] To evaluate the surgical techniques and clinical effects of mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of un-hydronephrotic cata-staghorn renal calculi.

5. England pubmed.ncbi.nlm.nih.gov

Concerns about stone free rate and procedure events of percutaneous nephrolithotripsy (PCNL) for 2-4 cm kidney stones by standard-PCNL vs mini-PCNL- comparative randomised study. [2023] To compare the efficacy and safety of standard percutaneous nephrolithotomy (PCNL) with mini- PCNL for kidney stones 2-4 cm.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Experience of mini-percutaneous nephrolithotomy in the treatment of large impacted proximal ureteral stones. [2022] To evaluate the efficacy and safety of mini- percutaneous nephrolithotomy (PCNL) in the treatment of large impacted proximal ureteral stones.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Mini-Percutaneous Nephrolithotomy for Complex Staghorn Stones in Children. [2019] To evaluate the safety and efficacy of percutaneous mini-nephrolithotomy (mini-PCNL) in children with complex staghorn stones.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of minimally invasive percutaneous nephrolithotomy for infantile nephrolithiasis. Single centre experience from Pakistan. [2023] To assess the efficacy and safety of mini-percutaneous nephrolithotomy (PCNL) for small renal stones 1-2 cm in size in infants less than one year.

9. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous-based management of Staghorn calculi in solitary kidney: combined mini percutaneous nephrolithotomy versus retrograde intrarenal surgery. [2015] Mini percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are well-established techniques with little morbidity. The combined use of standard PCNL and the mini-PCNL or the RIRS technique was evaluated and compared to investigate their own role in the management of staghorn calculi in solitary kidney.

10. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. [2022] Recent advances in technology have led to the implementation of mini- and micro-percutaneous nephrolithotomy (PCNL) as well as retrograde intrarenal surgery (RIRS) in the management of kidney stones.