Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery

NCT07568990 | Not Yet Recruiting

• 1 other identifier: ETIK-2026-01
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

retrograd intrarenal surgery; kidney stone; kidney

Outcome Measures

Primary Outcomes (1)

• Stone-free status

  Stone-free status is defined as the absence of residual stones on low-dose non-contrast computed tomography or plain urinary system radiography at 3 weeks postoperatively.

  At 3 weeks postoperatively

Secondary Outcomes (4)

• Operation time

  Measured during surgery, from incision to closure (intraoperative period)

• Length of hospital stay

  From postoperative admission to hospital discharge, assessed up to 30 days

• Intraoperative complications

  From start to completion of surgery (intraoperative period)

• Postoperative infectious complications

  From end of surgery to 7 days postoperatively

Study Arms (2)

Non-aspirating ureteral access sheath

EXPERIMENTAL

Patients undergoing retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath.

Device: Non-aspirating ureteral access sheath

Aspirating ureteral access sheath

EXPERIMENTAL

Patients undergoing retrograde intrarenal surgery (RIRS) using an aspirating ureteral access sheath.

Device: Aspirating ureteral access sheath

Interventions

Non-aspirating ureteral access sheath DEVICE

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

Non-aspirating ureteral access sheath

Aspirating ureteral access sheath DEVICE

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

Aspirating ureteral access sheath

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hitit University: lead

Related Publications (2)

• Kwok JL, Somani B, Sarica K, Yuen SKK, Zawadzki M, Castellani D, Persaud S, Chai CA, Kamal W, Tefik T, Tursunkulov AN, Soebhali B, Hajj AE, Ko R, Fong KY, Dragos L, Tanidir Y, Angerri O, Traxer O, Gauhar V. Multicenter outcome analysis of different sheath sizes for Flexible and Navigable Suction ureteral access sheath (FANS) ureteroscopy: an EAU Endourology collaboration with the global FANS study group. Urolithiasis. 2024 Nov 15;52(1):162. doi: 10.1007/s00240-024-01662-4.

  PMID: 39545972 RESULT

• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.

  PMID: 38789313 RESULT

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AHMET TAŞCI

CONTACT

+905531596690; ahmettasci400@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Participants will be randomly assigned into two parallel groups using a computer-based block randomization method. One group will undergo retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath, while the other group will undergo RIRS using an aspirating ureteral access sheath.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 6, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share