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Vacuum cleaner for kidneys? new technique may suck out stone fragments better

NCT ID NCT04519294

Disease control Sponsor: Calyxo, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to remove kidney stone pieces after laser treatment. Instead of using a tiny basket to grab each fragment, the SURE procedure gently vacuums them out. Researchers compared how many patients became completely stone-free with each method in 132 adults. The goal is to see if vacuuming works better at clearing all fragments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CVAC™ aspiration system (SURE procedure)
What this could lead to
If successful, this could offer a more complete way to remove kidney stone fragments, potentially reducing the need for follow-up procedures.
What could go wrong
This is a completed early-stage study with 132 participants. The new method may not be safer or more effective than standard basketing, and risks like injury or infection remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

132 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Candidate for ureteroscopy with laser lithotripsy; * Presence of renal stone(s); * Be willing and able to return for all study-related follow up procedures; and, * Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent. Exclusion Criteria: * BMI \> 45; * Significant comorbidities; * Bladder, ureteral or kidney abnormalities; * Pregnant individuals; or * Unable to meet the treatment and follow up protocol requirements.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis urolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney stone Renal stone Urolithiasis

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

  • Arizona Institute of Urology

    Tucson, Arizona, 85704, United States

  • Dell Medical School, The University of Texas at Austin

    Austin, Texas, 78712, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • New Jersey Urology

    Voorhees Township, New Jersey, 08043, United States

  • Prisma Health

    Greenville, South Carolina, 29650, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Urology Austin

    Austin, Texas, 78654, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

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