SURE vs. Standard Ureteroscopy for Kidney Stones

Not currently recruiting at 11 trial locations

Overseen By Dori Glenn

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Calyxo, Inc.

Disqualifiers: Bmi > 45, Significant comorbidities, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for removing kidney stones: the SURE procedure and the standard basket method used in ureteroscopy. Researchers seek to determine which method is more effective and has fewer side effects. Ideal candidates for this study are individuals with kidney stones who are eligible for ureteroscopy with laser lithotripsy. Participants must attend all follow-up visits as part of the trial.

As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance kidney stone treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SURE procedure is safe for kidney stone removal?

Research has shown that the SURE procedure is generally safe for removing kidney stones. Studies have found that SURE is both safe and effective, often outperforming the traditional basket method for clearing stones. One study reported that over 93% of stones were cleared just one day after the procedure, with a slight increase after a month. Additionally, very few residual stones remained. These studies reported no major side effects, suggesting that SURE is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SURE, a new method for treating kidney stones, because it has the potential to improve the efficiency and effectiveness of stone removal. Unlike standard ureteroscopy, which typically involves a process called basketing to retrieve the stones, SURE aims to enhance the precision of the procedure and reduce the time required. This could lead to faster patient recovery and fewer complications, making it an appealing alternative to current treatments.

What evidence suggests that this trial's treatments could be effective for kidney stones?

This trial will compare the SURE procedure with Standard Ureteroscopy for removing kidney stones. Research has shown that the SURE procedure is safe and effective, particularly for patients with large kidney stones, including those at high risk or unsuitable for other treatments. Specifically, the SURE method cleared stones in 96.2% of patients within 30 days and resulted in 73% fewer healthcare visits compared to standard ureteroscopy. These findings suggest that SURE could be a promising option for people with kidney stones. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who need treatment for kidney stones and are candidates for a procedure called ureteroscopy with laser lithotripsy. Participants must be able to attend all follow-up procedures, understand the study, and have signed consent. It's not open to pregnant people, those with a BMI over 45, significant other health issues, or abnormalities in the bladder, ureter or kidneys.

Inclusion Criteria

I have kidney stones.

I am a candidate for a procedure to remove kidney stones using lasers.

Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.

Exclusion Criteria

I have issues with my bladder, ureter, or kidneys.

Unable to meet the treatment and follow up protocol requirements.

You have other serious health problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the SURE procedure or standard basketing for kidney stone removal

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on Stone Free Rate

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard Ureteroscopy
• SURE

Trial Overview The study compares two methods of removing kidney stones: SURE (Steerable Ureteroscopic Renal Evacuation) versus standard basketing during ureteroscopy. The goal is to determine which method has better outcomes for patients.

How Is the Trial Designed?

Group I: Standard Ureteroscopy (Basketing) Active Control 1 Intervention

Group II: SURE Active Control 1 Intervention

Who Is Running the Clinical Trial?

Calyxo, Inc.

Lead Sponsor

Trials

2

Recruited

200+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39699687/

30-Day Results of the ASPIRE Study Despite randomization, baseline URS stone volume was higher (SURE 485.0 ± 432.5 mm3 vs URS 713.3 ± 558.5 mm3). The primary noninferiority end point was achieved ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10663695/

Steerable Ureteroscopic Renal Evacuation (SURE) for ... In this study we found that SURE is safe and effective for patients with large renal stones, including high-risk patients who are often poor candidates for PCNL ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/end.2024.0602

30-Day Results of the ASPIRE Study A multicenter study of large stone burden patients (mean 29.3 mm) showed that SURE is safe and effective for this population, including high-risk patients.

4. urologytimes.com urologytimes.com/view/sure-procedure-linked-with-lower-healthcare-utilization-vs-urs

SURE procedure linked with lower health care utilization vs ... The ASPIRE trial showed a 73% reduction in healthcare consumption events with SURE compared to URS over two years. The CVAC System demonstrated ...

5. urotoday.com urotoday.com/recent-abstracts/endourology-urolithiasis/stone-disease/163077-calyxo-debuts-reverse-deflection-cvac-system-and-reveals-groundbreaking-two-year-aspire-data-at-wcet-2025-underscoring-the-technology-s-role-in-advancing-endourology.html

Calyxo Debuts Reverse Deflection CVAC System and ... The study showed high stone clearance rates (93.8% at POD 1, 96.2% at POD 30) and low RSV (36.0 mm³ at POD 1 to 14.1 mm³ at POD 30), regardless ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422793/

Initial Safety and Feasibility of Steerable Ureteroscopic ... This initial study suggests SURE is safe, feasible, and may be more effective in stone removal postlaser lithotripsy compared to basketing.

7. biospace.com biospace.com/press-releases/aspire-level-1-outcomes-published-demonstrating-superior-stone-clearance-with-the-sure-procedure-using-the-cvac-system-vs-standard-ureteroscopy

ASPIRE Level 1 Outcomes Published Demonstrating ... SURE with the CVAC System achieved significantly superior stone clearance vs, URS at 30 days, with a mean reduction in stone volume of 97% for ...