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World's largest kidney stone surgery study launches

NCT ID NCT07622238

Knowledge-focused Sponsor: Foundation Endourology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This large observational study will follow 4,000 adults undergoing percutaneous nephrolithotomy (PCNL) for kidney stones across many international centers. Researchers will track which surgical techniques are used, how well they clear stones, and what complications occur. The goal is to learn which approaches work best for different patients.

What this could mean

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

What this could lead to
If successful, this study could help doctors choose the best surgical technique for kidney stones, leading to fewer complications and better recovery.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new cure or drug. Results may vary across centers and might not apply to all patients.

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.

Participants

4,000 people

The number who actually took part.

Started

Aug 2019

Finished

Jun 2026

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.

Who is studied

The study population consists of consecutive adult patients (18 years or older) diagnosed with renal or proximal ureteral calculi who are candidates for percutaneous stone surgery and are treated in real-world clinical practice settings. Participants are enrolled across 21 participating secondary and tertiary referral academic medical centers and hospitals globally, capturing a highly diverse and heterogeneous international population across multiple geographic regions

Ages

18 to 100 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: * Patient age 18 years or older at the time of enrollment. * Diagnosed with single or multiple renal calculi (including complex and staghorn calculi) or proximal ureteral stones. * Scheduled to undergo any primary or secondary percutaneous surgical stone intervention, including standard percutaneous nephrolithotomy (PCNL) or any of its miniaturized variations (Mini-PCNL, Ultra-mini PCNL, Super-mini PCNL, or Micro-PCNL). * Voluntarily provided written informed consent for participation and data utilization. Exclusion Criteria: * Patient age under 18 years. * Patients scheduled to undergo alternative primary treatment modalities for the targeted stone burden as a standalone procedure (e.g., retrograde intrarenal surgery \[RIRS\] or shockwave lithotripsy \[SWL\]). * Presence of an active, untreated urinary tract infection (UTI) or clinical urosepsis at the time of the scheduled surgical procedure. * Uncorrected severe coagulopathy or uncorrectable bleeding diathesis. * Missing, incomplete, or unavailable medical charts or follow-up records rendering outcome assessment impossible.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis Postoperative Complications ureterolithiasis urolithiasis

As listed by the trial registrant

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

Kidney calculi Urolithiasis

Contacts and locations

Locations

  • Foundation Endourology

    Sofia, Sofia-Grad, 1606, Bulgaria

  • Military Medical Academy, Department of Urology and Nephrology

    Sofia, Sofia-Grad, 1606, Bulgaria

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