COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURY

NCT07685587 | Recruiting

• 1 other identifier: 2026.170.05.32
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney stone disease is a common condition, and retrograde intrarenal surgery (RIRS) is a minimally invasive procedure frequently used to remove kidney stones. During RIRS, pressure inside the kidney can increase, which may contribute to temporary kidney injury. New aspiration-enabled access sheath systems have been developed to better control this pressure by continuously removing irrigation fluid during surgery. This study will compare aspiration and conventional access sheath systems to determine whether improved pressure control reduces early kidney injury. Blood and urine biomarkers (IL-18 and L-FABP), which can detect kidney damage earlier than standard kidney function tests, will be measured before and after surgery. The results may help identify surgical techniques that better protect kidney function and improve the safety of kidney stone treatment for patients.

Conditions

Urolithiasis

Keywords

retrograde intrarenal surgery; acute kidney injury; IL-18; L-FABP

Outcome Measures

Primary Outcomes (1)

• acute kidney injury

  Serum IL-18 and L-FABP levels at the stated timelines.

  preoperative, postoperative 24th hour and postoperative 7. days

Study Arms (2)

Patients operated with FANS-UAS

EXPERIMENTAL

Device: flexible and navigable ureteral access sheath

Patients operated with conventional-UAS

ACTIVE COMPARATOR

Device: conventional ureteral access sheath

Interventions

flexible and navigable ureteral access sheath DEVICE

Patients of RIRS operated with flexible and navigable ureteral access sheath

Patients operated with FANS-UAS

conventional ureteral access sheath DEVICE

Patients of RIRS operated with conventional ureteral access sheath

Patients operated with conventional-UAS

Eligibility Criteria

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

You may qualify if:

• Being 18 years of age or older
• Having a planned RIRS operation
• Providing written informed consent

You may not qualify if:

• Patients who do not give consent
• Patients who will undergo combined surgery
• Patients who have previously undergone endoscopic stone surgery
• Being under 18 years of age
• Patients with chronic kidney failure
• Patients with kidney malformations
• Patients with a solitary kidney
• Patients using nephrotoxic drugs

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.

  PMID: 22982421 BACKGROUND

• Ecer G, Sonmez MG, Guven S, Balasar M. RE: Wang, D. (2023). Re: comparison of retrograde intrarenal stone surgery with and without a ureteral access sheath using kidney injury molecule-1 (KIM-1) levels: a prospective randomized study by Gokhan Ecer, Mehmet Giray Sonmez, Arif Aydin, Cemile Topcu, Haider Nihad Izaddin Alalam, Selcuk Guven, and Mehmet Balasar. Urolithiasis, 51(1), 44. Urolithiasis. 2023 May 3;51(1):81. doi: 10.1007/s00240-023-01450-6. No abstract available.

  PMID: 37133619 BACKGROUND

MeSH Terms

Conditions

Urolithiasis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Kidney Diseases

Central Study Contacts

mehmet fatih M. şahin, associate professor

CONTACT

+90 555 551 1871; mfatihsahin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)