RecruitingNot ApplicableNCT07101809

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

Sponsor

Calyxo, Inc.

Enrollment

150 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

Renal Stones Kidney Stones Urolithiasis Stones, Kidney

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Standard Ureteroscopy (URS) and a medical device called Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System for people with kidney stones, renal stones, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESteerable 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).

DEVICEStandard 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.