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New flexible suction sheath may improve kidney stone removal in children

NCT ID NCT07689565

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests whether a new flexible and navigable suction ureteral access sheath (FANS) works better than the standard sheath for removing kidney stones smaller than 2 cm in children. Sixty children will be randomly assigned to one of the two devices during a procedure called flexible ureterorenoscopy. The study measures how many stones are completely removed, how long the surgery takes, and any complications.

What this could mean

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

Active substance
Flexible and Navigable Suction Ureteral Access Sheath (FANS)
What this could lead to
If successful, this could offer a safer, more effective way to remove kidney stones in children, reducing the need for repeat procedures.
What could go wrong
This is a small, early-stage trial with only 60 children, so results may not apply to all patients. The new device may not improve outcomes and could carry unknown 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 60 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

1 year to 18 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. Pediatric patients (age ≤ 18 years) 2. Patients with renal stones less than 2 cm 3. Indicated for flexible ureterorenoscopy 4. Fit for general anesthesia 5. Informed consent obtained from parents or guardians Exclusion Criteria: 1. Stones larger than 2 cm 2. Active urinary tract infection 3. Congenital urinary tract anomalies affecting access 4. Previous ureteral surgery affecting the ureter 5. Coagulopathy or unfit for surgery

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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 Nephrolithiasis Pediatric urolithiasis

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.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Tanta University

    Tanta, Gharbia Governorate, 31527, Egypt

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