Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

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

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.

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