Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

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.

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stones Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Stones Stones, Kidney Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System

Device

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).

Other names: CVAC

Standard Ureteroscopy (URS)

Device

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.

Primary outcomes

Residual Stone Volume (RSV)

Time frame: 30-Day

Sponsors and collaborators

Lead sponsor

Calyxo, Inc.

Industry

Registry information

Official study 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

Acronym: TRUST

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2029
First posted: Aug 3, 2025
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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