Actively Recruiting
Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC System Compared to Standard Ureteroscopy With No Suction for Treating Kidney Stones: A Prospective, Randomized Trial
Led by Calyxo, Inc. · Updated on 2026-05-20
150
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two treatments for kidney stones, known as urolithiasis, in this prospective, randomized study. The trial evaluates Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System against standard ureteroscopy (URS) with laser lithotripsy. The study aims to understand how well these methods work to treat renal stones by measuring outcomes such as the volume of residual stone left 30 days after treatment. The trial includes two treatment groups. One uses standard ureteroscopy, where a laser breaks kidney stones into small pieces and a stent is placed to help pass remaining fragments. The other group uses the CVAC Aspiration System, a steerable device that integrates vision, irrigation, and suction to remove kidney stones and fragments. Both treatments are performed in a clinical setting by urologists, and participants are randomly assigned to one of the two methods. Participants will undergo treatment and follow-up visits to assess stone removal success and safety. Researchers will monitor residual stone volume 30 days after the procedure. Participants must be willing and able to complete all study visits and procedures. The study will continue through 2029, and all participants will be assessed for treatment outcomes and any complications during the study period.
CONDITIONS
Brief Title
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for ureteroscopy with laser lithotripsy
- Willing and able to return for all study-related follow-up procedures
- Provided informed consent using the IRB approved form
You will not qualify if you...
- Untreated urinary tract infection at the time of the procedure
- Significant other health problems
- Bladder, ureteral, or kidney abnormalities
- Pregnant individuals
- Unable to meet treatment and follow-up protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo either Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System or Standard Ureteroscopy (URS) to treat kidney stones.
1 visit (in-person)
Duration - 30 days
Participants are followed up to assess treatment outcomes and safety after the procedure.
1 to 2 visits depending on stent removal and recovery
Trial Site Locations
Total: 3 locations
1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
3
The University of Texas at Austin, Dell Medical School
Austin, Texas, United States, 78712
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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