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NCT07101809NARecruiting

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

Calyxo, Inc.

Start Date

5/21/2026

Completion Date

7/1/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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) Exclusion Criteria: * Untreated urinary tract infection at the time of the index procedure * Significant comorbidities * Bladder, ureteral or kidney abnormalities * Pregnant individuals * Unable to meet the treatment and follow up protocol requirements

Interventions

DEVICE

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

DEVICE

Standard Ureteroscopy (URS)

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Conditions

UrolithiasisStones, KidneyRenal StonesKidney Stones

Locations

The University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

University of Florida

Gainesville, Florida 32611

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania 19004

United States

The University of Texas at Austin, Dell Medical School

Austin, Texas 78712

United States