NCT07101809

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Calyxo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urolithiasis
• Stones, Kidney
• Renal Stones
• Kidney Stones

Interventions

Type	Name	Description
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).
DEVICE	Standard Ureteroscopy (URS)	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2025-08-03
• Last updated: 2025-09-18

Regulatory

• FDA-regulated device study