Clinical Trial

Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

Recruiting
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Summary
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-11
notable Primary completion pushed: 2026-05-11 -> 2027-04-11 2026-06-11
minor Completion pushed: 2026-05-11 -> 2027-05-11 2026-06-11
Trial Details
NCT Number NCT07568990
Lead Sponsor Hitit University
Conditions Kidney Stones
Enrollment 70 participants
Start Date 2026-04-20
Primary Completion 2027-04-11 (estimated)
Study Completion 2027-05-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-10