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NOT YET RECRUITING
NCT07101809
NA

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Sponsor: Calyxo, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-09

Completion Date

2029-09

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

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.