RecruitingNot ApplicableNCT07568990

Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery


Sponsor

Hitit University

Enrollment

70 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Aspirating ureteral access sheath and a medical device called Non-aspirating ureteral access sheath for people with kidney stones. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENon-aspirating ureteral access sheath

A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.

DEVICEAspirating ureteral access sheath

A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.


Locations(1)

Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye

Çorum, Çorum, Turkey (Türkiye)

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NCT07568990


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