Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Recruiting

Evaluating the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) With the CVAC® System Compared to Standard Ureteroscopy With no Suction for the Treatment of Renal Stones: a Prospective, Randomized Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System (device)
Standard Ureteroscopy (URS) (device)

Sponsor: Calyxo, Inc. · Participants: 150 · Started: May 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07101809

Locations in the U.S.

Alabama	The University of Alabama at Birmingham, Birmingham
Florida	University of Florida, Gainesville
New York	Icahn School of Medicine at Mount Sinai, New York
Pennsylvania	MidLantic Urology, Bala-Cynwyd
Texas	The University of Texas at Austin, Dell Medical School, Austin

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.