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Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

NCT07568990 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Kidney Stones

Interventions

DEVICE

Non-aspirating ureteral access sheath

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

DEVICE

Aspirating ureteral access sheath

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

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-05-11
Completion
2026-05-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07568990 on ClinicalTrials.gov