CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones

A Prospective Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® Set

The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.

Inclusion Criteria:

• Candidate for ureteroscopy with laser lithotripsy;
• Be willing and able to return for and respond to all study-related follow up procedures; and,
• Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).

Exclusion Criteria:

• Significant morbidities;
• Unable to meet the treatment and follow up protocol requirements; and,
• Ureteral or kidney abnormalities.