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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Namik Kemal University Academic / other |
| Locations | 1 site (Tekirdağ) |
| Status | Recruiting |
| Started | May 4, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07685587 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
- Study coordinator: mehmet fatih M. şahin, associate professor
- Email: mfatihsahin@gmail.com
- Phone: +90 555 551 1871
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Audio consent with human voice or AI-voice added to written consent for ureteroscopy
This study tests if listening to an audio version of the consent form, read by a real urologist or by an AI-cloned voice, helps adults in Turkey understand their ureteroscopy or RIRS consent better than the written form alone.
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Long-term safety of UAS-assisted vs sheathless RIRS in adults with kidney stones
This study tests whether using a ureteral access sheath during the initial RIRS affects long-term safety and outcomes in adults with kidney stones ≤20 mm.
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See if pelvic floor endurance relates to stent symptoms after ureteroscopy
This study tests whether a ultrasound measure of pelvic floor endurance (PFFI) can predict ureteral stent-related symptoms after ureteroscopy or RIRS in adults 18–65.
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Gentamicin Irrigation and Suction Ureteral Access in Kidney Stone Surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.