Aspirating vs non-aspirating ureteral access sheath in RIRS for kidney stones
Official title: The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery
Run by Hitit University · NCT07568990 · Data updated 2026-11-12
This trial tests whether using an aspirating ureteral access sheath during retrograde intrarenal surgery improves stone clearance and reduces complications compared with a non-aspirating sheath in adults with small kidney stones.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Hitit University Academic / other |
| Locations | 1 site (Çorum, Çorum) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | April 11, 2027 |
| Study ends | May 11, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07568990 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with kidney stones smaller than 2 cm scheduled for RIRS and able to provide informed consent.
✕Probably not a fit
Patients with active infection, coagulopathy, pregnancy, or inability to tolerate lithotomy position may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study compares two ureteral access sheath technologies used during retrograde intrarenal surgery for kidney stones under 2 cm. Participants are 18 to 75 years old and are assigned to either an aspirating or non-aspirating sheath, with standardized surgical technique. Primary outcome is stone-free rate after surgery; secondary outcomes include operative and fluoroscopy times, hospital stay, Clavien-Dindo complications, infection-related parameters, and need for ureteral stenting. Demographic, stone, and perioperative data will be collected with follow-up assessments to determine stone clearance and safety. The study aims to clarify whether suction-assisted sheaths offer meaningful advantages over conventional devices.
Why it matters
Potential benefit: If successful, patients may experience higher stone-free rates and fewer complications, potentially informing best-practice choices for RIRS.
How similar studies have gone: Prior data on aspirating versus non-aspirating sheaths are limited, making this a novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 18 and 75 years * Patients diagnosed with kidney stones smaller than 2 cm * Patients scheduled for retrograde intrarenal surgery (RIRS) * Patients who provide written informed consent Exclusion Criteria: * Patients with active urinary tract infection * Patients with coagulopathy * Pregnant patients * Patients unable to tolerate the lithotomy position * Patients with incomplete clinical or laboratory data
Where it's running
-
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ahmet Taşci
- Email: ahmettasci400@gmail.com
- Phone: +905531596690
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial will test whether the HugeMed 6.3 Fr flexible ureteroscope gives similar stone-free results while lowering costs compared with traditional flexible ureteroscopes in adults having RIRS for stones up to 2.5 cm.
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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.