Trial of SURE vs. Standard Ureteroscopy for Kidney Stones

This study is comparing two ways to treat kidney stones (urolithiasis): Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System, and standard ureteroscopy (URS). SURE uses a steerable catheter with vision, irrigation, and aspiration to remove stones. Standard URS uses a laser to break stones into small pieces, followed by a stent to help them pass. The goal is to see which method leaves less stone material behind (Residual Stone Volume) after 30 days. You may be able to join if you are an adult who needs ureteroscopy with laser lithotripsy and are willing to attend follow-up appointments. You cannot join if you have an untreated urinary tract infection. The study plans to enroll 150 participants, but its current status is unclear.

Study design
This is a multi-center study where participants are randomly assigned to one of two treatment groups (SURE or standard URS) with equal chances.
What's involved
You would need to be willing and able to return for and respond to all study-related follow-up procedures.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for success, Residual Stone Volume, is taken 30 days after the procedure.

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NCT07101809

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Recruiting
NAAges 18+InterventionalTreatment
Calyxo, Inc.
~150 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC SystemStandard Ureteroscopy (URS)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Residual Stone Volume (RSV)
Measured over 30-Day
Urolithiasis
Stones, Kidney
Renal Stones
Kidney Stones
5 sites across 5 states
Alabama1
Florida1
New York1
Pennsylvania1
Texas1

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Eligibility criteria

Inclusion

Candidate for ureteroscopy with laser lithotripsy
Be willing and able to return for and respond to all study-related follow up procedures
Have been informed of the nature of the study and has provided informed consent using the IRB approved informed consent (ICF)

Exclusion

Untreated urinary tract infection at the time of the index procedure
Significant comorbidities
Bladder, ureteral or kidney abnormalities
Pregnant individuals
Unable to meet the treatment and follow up protocol requirements
  • Residual Stone Volume (RSV)30-Day