Robotic Surgery for Kidney Stones

(STAR Trial)

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

15 Participants Needed

What You Need to Know Before You Apply

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 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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 7 8 9 10}

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 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]

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]

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]

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]

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]

Citations

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]

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]

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]

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

[Mini-percutaneous nephrolithotomy in the treatment of un-hydronephrotic cata-staghorn renal calculi]. [2007]

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]

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

Experience of mini-percutaneous nephrolithotomy in the treatment of large impacted proximal ureteral stones. [2022]

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

Mini-Percutaneous Nephrolithotomy for Complex Staghorn Stones in Children. [2019]

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

Safety and efficacy of minimally invasive percutaneous nephrolithotomy for infantile nephrolithiasis. Single centre experience from Pakistan. [2023]

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]

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

Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. [2022]