Stent before surgery: a new test for kidney stone treatment

NCT ID NCT07773090

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This trial tests whether placing a temporary stent in the ureter a week or two before kidney stone surgery helps clear stones more completely than going straight to surgery. Adults with a single kidney stone between 10 and 20 mm will be randomly assigned to either pre-stenting or direct surgery. The study tracks stone-free rates, complications, and recovery to see if the extra step is worthwhile.

What this could mean

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

Active substance
Preoperative double-J ureteral stenting followed by retrograde intrarenal surgery
What this could lead to
If pre-stenting proves beneficial, it could become a standard step before kidney stone surgery, improving success rates and reducing complications.
What could go wrong
The trial is relatively small and may not account for all patient variations. Pre-stenting can cause discomfort and urinary tract infections, and the benefit over direct surgery is uncertain.

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 270 people

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

Started

Aug 2026

Expected to finish

Nov 2028

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 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: * Participants must meet all of the following criteria: * Adults aged 18-70 years. * Unilateral renal calculi. * Maximum total renal stone burden of 10-20 mm. * Planned treatment with RIRS. * Suitable candidate for elective endoscopic stone treatment. * Negative or appropriately treated preoperative urine culture. * Ability to provide written informed consent. * Ability and willingness to comply with postoperative follow-up, including non-contrast CT at 4 weeks after the final RIRS procedure. Exclusion Criteria: * Participants will be excluded for any of the following: * Bilateral renal calculi requiring simultaneous surgical treatment. * Active urinary tract infection, sepsis, or infected obstruction requiring urgent drainage. * Solitary kidney when randomization is considered clinically unsafe. * Known ureteral stricture or congenital ureteral abnormality likely to interfere with ureteroscopic access. * Previous failed ipsilateral ureteroscopic access requiring clinically indicated pre-stenting. * Existing ipsilateral ureteral stent or nephrostomy. * Previous ureteral reconstruction or urinary diversion. * Total renal stone burden greater than 20 mm. * Staghorn calculi. * Uncorrected coagulopathy. * Pregnancy. * Severe uncorrected cardiopulmonary disease precluding anesthesia. * Inability or unwillingness to provide informed consent. * Inability or unwillingness to comply with follow-up. * Any other condition judged by the treating surgeon to make randomization or RIRS clinically inappropriate or unsafe.

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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.

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  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

  • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

    RECRUITING

    Cairo, Egypt

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