Robotic Surgery for Kidney Stones

(STAR Trial)

No longer recruiting at 3 trial locations

Overseen By Study L. Contact, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auris Health, Inc.

Disqualifiers: Solitary kidney, Pregnant, Ureteral stones, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robotic-assisted surgery for removing kidney stones. The goal is to evaluate the procedure's effectiveness, safety, and ability to clear stones post-surgery. Individuals with kidney stones larger than 1 cm and normal kidney anatomy might be suitable candidates for this trial. Those who have struggled with kidney stones and are exploring new treatment options may find this trial offers a potential solution. As an unphased trial, it provides a unique opportunity to explore innovative treatments for kidney stones.

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 prior data suggests that this robotic-assisted mini-PCNL is safe for kidney stone removal?

Research has shown that robotic-assisted mini-PCNL, a procedure to remove kidney stones, is generally safe and well-tolerated. One study found that both robotic-assisted PCNL and a similar surgery effectively and safely treat large kidney stones in older adults. Early results from patients who underwent robotic-assisted mini-PCNL demonstrated promising safety outcomes. This procedure uses advanced technology with imaging and robotic control to precisely and safely remove kidney stones. Overall, these findings suggest that robotic-assisted mini-PCNL is a safe option for patients needing kidney stone surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted mini-PCNL for kidney stones because it offers a cutting-edge approach to stone removal. Unlike traditional techniques like standard percutaneous nephrolithotomy or ureteroscopy, this method uses the MONARCH Platform, which allows for enhanced precision with electro-mechanical articulation. This means doctors can navigate the urinary tract with greater control, potentially improving visualization and access during the procedure. This innovative approach could lead to more effective stone removal and a quicker recovery time for patients.

What evidence suggests that robotic-assisted mini-PCNL is effective for kidney stones?

Research has shown that a robot-assisted method called mini-Percutaneous Nephrolithotomy (mini-PCNL) effectively treats large kidney stones. In this trial, participants will undergo a robotic-assisted mini-PCNL procedure using the MONARCH Platform. Studies indicate that this procedure allows direct access to the kidney, which is crucial for stone removal. The MONARCH Platform offers precise control to efficiently reach and treat kidney stones. Early results suggest that this technique is both safe and effective, making it a promising option for kidney stone removal. ^{1 3 6 7 8}

Who Is on the Research Team?

Margaret A. Knoedler, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) using the MONARCH Platform for kidney stone removal

1 day

Procedure Visit (Day 0)

Follow-up

Participants are monitored for stone clearance and adverse events post-operatively

90 days

Post-operative Day 30 and Day 90

What Are the Treatments Tested in This Trial?

Interventions

• Robotic-assisted mini-PCNL

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Auris Health, Inc.

Lead Sponsor

Trials

6

Recruited

780+

Published Research Related to This Trial

A survey of 30 urologists revealed that treatment choice for urolithiasis is primarily influenced by stone size and the surgical volume of the center, with Mini-PCNL being favored for its effectiveness and safety, especially for stones 1-2 cm in size.

Micro-PCNL had a significantly lower stone-free rate compared to Regular-PCNL, although this difference was not observed for stones sized 1-2 cm, indicating that while miniaturized techniques are popular, their effectiveness can vary based on stone size.

NCBI (Pubmed)

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? Zanetti, SP., Talso, M., Palmisano, F., et al.[2019]

In a study of 60 patients with 1-2 cm renal stones, retrograde intrarenal surgery (RIRS) resulted in significantly less postoperative pain compared to Mini percutaneous nephrolithotomy (Mini-PCNL), although RIRS had a longer operating time (72.23 minutes vs. 44.07 minutes).

Both RIRS and Mini-PCNL were found to be safe with similar complication rates and stone clearance rates, indicating that either technique can be effectively used for managing renal stones of this size.

NCBI (Pubmed)

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. Kanchi, VBR., Pogula, VMR., Galeti, EH., et al.[2022]

In a study of 45 patients with staghorn calculi, the combination of standard PCNL and RIRS resulted in a significantly shorter operation time (109.8 minutes) compared to the combination of standard PCNL and mini-PCNL (128.8 minutes).

The combined standard PCNL and RIRS approach also achieved a higher stone-free rate (90.9%) compared to the standard PCNL and mini-PCNL method (65.2%), indicating it may be a more effective treatment option with less blood loss and lower morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous-based management of Staghorn calculi in solitary kidney: combined mini percutaneous nephrolithotomy versus retrograde intrarenal surgery. Zhong, W., Zhao, Z., Wang, L., et al.[2015]

In a study of 70 patients with renal stones larger than 10 mm, retrograde intrarenal surgery (RIRS) achieved a higher stone-free rate of 97.0% compared to 85.7% for mini-PCNL, although this difference was not statistically significant (P = .199).

While both procedures were safe, RIRS resulted in more immediate postoperative pain and a greater need for analgesics compared to mini-PCNL, indicating a trade-off between efficacy and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-percutaneous Nephrolithotomy vs Retrograde Intrarenal Surgery for Renal Stones Larger Than 10 mm: A Prospective Randomized Controlled Trial. Lee, JW., Park, J., Lee, SB., et al.[2016]

Mini-percutaneous nephrolithotomy (mini-PCNL) is an effective and less traumatic surgical option for treating un-hydronephrotic cata-staghorn renal calculi, with successful establishment of access in all 46 patients studied.

The procedure resulted in complete stone removal in 39.1% of cases, and when combined with extracorporeal shock-wave lithotripsy (ESWL), it provided a comprehensive approach to managing residual stones, making it a preferable alternative to open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mini-percutaneous nephrolithotomy in the treatment of un-hydronephrotic cata-staghorn renal calculi]. Gao, N., Chen, HQ., Qi, L., et al.[2007]

Percutaneous nephrolithotomy (PCNL) techniques have a higher stone-free rate compared to retrograde intrarenal surgery (RIRS), but they also come with increased complication rates and greater blood loss, making RIRS a safer option for smaller stones.

RIRS is associated with shorter hospital stays than both standard PCNL and minimally invasive percutaneous procedures (MIPPs), suggesting it may be the preferred treatment for kidney stones less than 2 cm in size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. De, S., Autorino, R., Kim, FJ., et al.[2022]

Mini-percutaneous nephrolithotomy (PCNL) is a safe and effective treatment for large impacted proximal ureteral stones, with a high success rate of 95.7% in a study of 163 patients.

The procedure had a mean operation time of 37 minutes and a short postoperative hospital stay of 3.6 days, with no major complications reported, indicating its safety and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of mini-percutaneous nephrolithotomy in the treatment of large impacted proximal ureteral stones. Long, Q., Guo, J., Xu, Z., et al.[2022]

Percutaneous mini-nephrolithotomy (mini-PCNL) is an effective treatment for complex staghorn stones in children, achieving an initial stone-free rate of 78%, which improved to 89% after additional procedures.

The procedure is generally safe, with a complication rate of 17%, including serious issues like hydrothorax and the need for blood transfusions, but these rates are comparable to existing literature on similar treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini-Percutaneous Nephrolithotomy for Complex Staghorn Stones in Children. Rashid, AO., Amin, SH., Al Kadum, MA., et al.[2019]

Mini-percutaneous nephrolithotomy (PCNL) is an effective treatment for small renal stones (1-2 cm) in infants under one year, achieving a stone-free rate of 90.2% after one month in a study of 51 infants.

The procedure demonstrated a good safety profile, with only 13.7% of patients experiencing minor complications, such as fever and transient hematuria, none of which required additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of minimally invasive percutaneous nephrolithotomy for infantile nephrolithiasis. Single centre experience from Pakistan. Ahmad, T., Minallah, N., Khaliq, N., et al.[2023]

Mini-PCNL is a safe and effective treatment for kidney stones sized 2-4 cm, showing fewer intra-operative complications and a shorter hospital stay compared to standard-PCNL, based on a study of 80 patients.

While the stone-free rates were similar (80% for mini-PCNL vs. 85% for standard-PCNL), mini-PCNL required less post-operative analgesia and had a longer mean operative time (95 min vs. 72 min for standard-PCNL).

NCBI (Pubmed)

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. Wishahi, M., El Feel, A., Elkhouly, A., et al.[2023]

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Comparative Analysis of Surgical Outcomes Between ...

Our study reveals both RAPL and mini-PCNL are effective and safe options for treating large renal stones (>2 cm) in older adults.

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This paper presents a robotic system designed to enable accurate kidney access by combining 3D anatomical modeling with real-time ultrasound guidance.

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NCT06330701 | Stone Access and Removal (STAR) Study

The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous ...