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Smaller tube, same stone removal: new kidney stone surgery tested

NCT ID NCT05088213

Disease control Sponsor: The First Affiliated Hospital of Guangzhou Medical 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This trial compares two surgical techniques for removing kidney stones that are 2 to 4 centimeters in size. The newer method, called suction mini-PCNL, uses a smaller tube and suction to remove stone fragments, while the standard method uses a larger tube. The goal is to see if the newer method works just as well at clearing stones while causing fewer complications like bleeding and infection. The study involves 960 adults aged 18 to 70 across multiple international centers.

What this could mean

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

Active substance
suction mini percutaneous nephrolithotomy (mini-PCNL) procedure
What this could lead to
If successful, this could offer a safer, less invasive surgical option for removing medium-to-large kidney stones, with less bleeding and shorter hospital stays.
What could go wrong
This is a noninferiority trial, meaning it aims to show the new method is not worse than the standard. It may still have higher infection risk or longer surgery time.

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

960 people

The number who actually took part.

Started

Dec 2021

Finished

Dec 2025

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 70 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: 1. Adults aged 18-70 years. 2. American Society of Anesthesiology (ASA) score of 1-2. 3. Kidney stones measuring 2-4 cm in diameter on non-contrast computer tomography. 4. Ability to provide written informed consent and adhere to trial requirements. Exclusion Criteria: 1. Anatomy abnormalities, such as urinary diversion, horseshoe kidney, transplanted kidney, or ureteropelvic junction obstruction. 2. Untreated acute urinary tract infection (UTI). 3. Patients on anticoagulant/antithrombotic therapy, or with uncorrected coagulopathies. 4. Patients who decline trial enrolment or cannot adhere to trial requirements.

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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

Contacts and locations

Locations

  • Department of Urology, Minimally invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510230, China

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