Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Aspiration-enabled vs conventional ureteral access sheath for RIRS in kidney stone patients

Official title: Comparison of the Effects of Flexible and Navigable Suction With Conventional Ureteral Access Sheaths During Retrograde Intrarenal Surgery on Postoperative Acute Renal Injury With IL-18 and L-FABP Biomarkers: A Prospective Randomised Study

Run by Namik Kemal University · NCT07685587 · Data updated 2026-11-12

This study tests whether using an aspiration-enabled access sheath during retrograde intrarenal surgery (RIRS) helps prevent early kidney injury compared with conventional sheaths in adults with kidney stones.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment108 (estimated)
SponsorNamik Kemal University
Academic / other
Locations1 site (Tekirdağ)
StatusRecruiting
StartedMay 4, 2026
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedJuly 6, 2026
Trial IDNCT07685587 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+ years) planned for RIRS who consent and have no excluded conditions.

Probably not a fit

Patients with chronic kidney failure, solitary kidney, kidney malformations, prior endoscopic stone surgery, or those on nephrotoxic drugs may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In patients undergoing retrograde intrarenal surgery for kidney stones, intrarenal pressure can rise during irrigation. The trial compares an aspiration-enabled ureteral access sheath to a conventional sheath to see if better pressure control reduces early kidney injury, using biomarkers IL-18 and L-FABP measured before and after surgery. It is an interventional study enrolling adults planned for RIRS, with specific exclusions such as prior endoscopic stone surgery or chronic kidney failure. The study is led by Namik Kemal University in Tekirdağ and evaluates safety and potential renal benefits of the new system.

Why it matters

Potential benefit: If successful, the aspiration-enabled sheath could lower the risk of early kidney injury during RIRS and improve patient safety.

How similar studies have gone: Previous work suggests that better irrigation and pressure control can improve safety, but results with aspiration-enabled systems in RIRS are still being evaluated.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Tekirdag Namık Kemal University
    Tekirdağ, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.