An interventional study of Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and Standard Ureteroscopy (URS) in Urolithiasis, Stones, Kidney and Renal Stones, sponsored by Calyxo, Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Calyxo, Inc. · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Device: Standard Ureteroscopy (URS)
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).
Device: Steerable 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).
Also known as: CVAC
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.
Residual Stone Volume (RSV)
Time frame: 30-Day
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Calyxo, Inc.