Kidney Stones, Renal Stones, Stones, Kidney, Urolithiasis
Conditions
Keywords
ureteroscopy, CVAC, SURE
Brief 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.
Interventions
DEVICESteerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System
The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration for the treatment and removal of urinary stones (kidney stones, fragments, and dust).
DEVICEStandard Ureteroscopy (URS)
Arm Description: This is a treatment in which the urologist uses a laser to break a kidney stone into very small pieces and then places a tool called a stent to allows the remaining pieces to fall out.
Sponsors
Calyxo, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual Stone Volume (RSV) | 30-Day |
Countries
United States
Outcome results
None listed