15 Participants Needed

Robotic Surgery for Kidney Stones

(STAR Trial)

Recruiting at 3 trial locations
NL
SL
Overseen ByStudy L. Contact, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Auris Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.56789

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.178910

Who Is on the Research Team?

MA

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.
See 1 more

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.
See 3 more

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?
1Treatment groups
Experimental Treatment
Group I: Robotic mini-Percutaneous Nephrolithotomy (PCNL)Experimental Treatment1 Intervention

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

Find a Clinic Near You

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.
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.
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.
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]

Citations

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]
Prospective study on Comparison of outcomes of mini percutaneous nephrolithotomy versus retrograde intrarenal surgery for renal stones of 1-2 cm size. [2022]
Mini-percutaneous Nephrolithotomy vs Retrograde Intrarenal Surgery for Renal Stones Larger Than 10 mm: A Prospective Randomized Controlled Trial. [2016]
[Mini-percutaneous nephrolithotomy in the treatment of un-hydronephrotic cata-staghorn renal calculi]. [2007]
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]
Experience of mini-percutaneous nephrolithotomy in the treatment of large impacted proximal ureteral stones. [2022]
Mini-Percutaneous Nephrolithotomy for Complex Staghorn Stones in Children. [2019]
Safety and efficacy of minimally invasive percutaneous nephrolithotomy for infantile nephrolithiasis. Single centre experience from Pakistan. [2023]
Percutaneous-based management of Staghorn calculi in solitary kidney: combined mini percutaneous nephrolithotomy versus retrograde intrarenal surgery. [2015]
Percutaneous nephrolithotomy versus retrograde intrarenal surgery: a systematic review and meta-analysis. [2022]
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