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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
Pennsylvania
MidLantic Urology
RECRUITING
Bala-cynwyd
Texas
The University of Texas at Austin, Dell Medical School
RECRUITING
Austin
Time Frame
Start Date: 2026-05
Estimated Completion Date: 2029-07
Participants
Target number of participants: 150
Treatments
Active_comparator: Standard Ureteroscopy (URS)
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.
Active_comparator: Steerable Ureteroscopic Renal Evacuation (SURE) with 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).
Related Therapeutic Areas
Sponsors
Leads: Calyxo, Inc.