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New kidney stone surgery could be safer and more effective

NCT ID NCT07159503

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new procedure called VISOR against the standard surgery (PCNL) for removing kidney stones that are 2 to 4 centimeters in size. About 170 adults will be randomly assigned to one of the two surgeries. The main goal is to see how many people are stone-free within 24 hours and at one month after surgery, and to compare side effects like fever or injury.

What this could mean

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

Active substance
Vortex Intelligence Stone Optimized Removal (VISOR) procedure
What this could lead to
If successful, VISOR could offer a safer and more effective way to remove medium-sized kidney stones, reducing complications and improving recovery.
What could go wrong
This is a relatively early study with 170 participants, so results may not apply to everyone. The new procedure might not be better than the standard surgery and could have unexpected risks.

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

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: * Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm * Age between 18 and 80 years, regardless of gender * Mentally sound and able to comprehend study details and provide informed consent Exclusion Criteria: * Presence of ureteral stricture or history thereof * Previous open or laparoscopic renal and/or ureteral surgery * Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery * Pregnancy, lactation, or menstruation at the time of surgery * ASA classification \> Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery * Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney * Coagulation dysfunction (e.g., INR \> 1.5 or platelet count \< 80 × 10⁹/L) * Intraoperative failure to successfully place the ureteral access sheath

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

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

Kidney calculi Kidney stones

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 230000, China

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