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New aspiration sheath may protect kidneys during stone surgery

NCT ID NCT07685587

Disease control Sponsor: Namik Kemal University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial compares a new aspiration-enabled access sheath to a conventional one during retrograde intrarenal surgery (RIRS) for kidney stones. The new sheath continuously removes irrigation fluid to control pressure inside the kidney, potentially reducing temporary kidney injury. Researchers measure early kidney damage using blood and urine biomarkers (IL-18 and L-FABP) before and after surgery. The study includes 108 adults scheduled for RIRS, excluding those with chronic kidney failure or other kidney conditions.

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 ureteral access sheath
What this could lead to
If the new sheath reduces kidney injury, it could become a safer standard for kidney stone surgery, protecting kidney function better than current tools.
What could go wrong
This is a small, early-stage study (108 participants) measuring temporary biomarkers, not long-term outcomes. The new sheath may not meaningfully improve patient recovery.

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 108 people

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

Started

May 2026

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

18 years and older

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: * Being 18 years of age or older * Having a planned RIRS operation * Providing written informed consent Exclusion Criteria: * Patients who do not give consent * Patients who will undergo combined surgery * Patients who have previously undergone endoscopic stone surgery * Being under 18 years of age * Patients with chronic kidney failure * Patients with kidney malformations * Patients with a solitary kidney * Patients using nephrotoxic drugs

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Conditions

The condition(s) this trial relates to.

acute kidney injury urolithiasis

As listed by the trial registrant

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

Urolithiasis

How to take part

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  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

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Contacts and locations

Locations

  • Tekirdag Namık Kemal University

    RECRUITING

    Tekirdağ, Turkey (Türkiye)

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