NCT07101809NARecruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Calyxo, Inc.
Start Date
5/21/2026
Completion Date
7/1/2029
Summary
The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DEVICE
Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
DEVICE
Standard Ureteroscopy (URS)
Conditions
UrolithiasisStones, KidneyRenal StonesKidney Stones
Locations
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
University of Florida
Gainesville, Florida 32611
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
The University of Texas at Austin, Dell Medical School
Austin, Texas 78712
United States