Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

Recruiting now · Not applicable

Conditions studied: Kidney Stones

In brief

This prospective, randomized, comparative study aims to evaluate the impact of aspirating and non-aspirating ureteral access sheaths on success rates and complications in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones. A total of 70 patients with renal stones smaller than 2 cm will be enrolled and randomly assigned to two groups. One group will undergo RIRS using a non-aspirating ureteral access sheath, while the other group will be treated using an aspirating ureteral access sheath. The primary outcome of the study is the stone-free rate, which will be assessed at postoperative follow-up. Secondary outcomes include operative time, fluoroscopy time, length of hospital stay, postoperative complications according to the Clavien-Dindo classification, infection-related parameters, and the need for ureteral stenting. The study aims to determine whether the use of an aspirating access sheath improves surgical outcomes by reducing intrarenal pressure, enhancing visualization, and decreasing complication rates. The findings are expected to contribute to optimizing device selection and improving clinical outcomes in endoscopic kidney stone surgery.

Key facts

Study ID

NCT07568990

Run by

Hitit University

People needed

70

Starts

2026-04-20

Expected to finish

2027-05-11

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye — Çorum, Çorum, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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