UrolithiasisFANSNCT07685587
COMPARISON OF FANS VS CONVENTIONAL URETERAL ACCESS SHEATH in RIRS on POSTOPERATIVE ACUTE KIDNEY INJURY
A study testing flexible and navigable ureteral access sheath and conventional ureteral access sheath in people with Urolithiasis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- flexible and navigable ureteral access sheath and conventional ureteral access sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Having a planned RIRS operation
- Providing written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tekirdag Namık Kemal University
Tekirdağ
Mehmet F. Şahin, associate professor, +90 555 551 1871, mfatihsahin@gmail.com
About this study
Official title: Comparison of the Effects of Flexible and Navigable Suction With Conventional Ureteral Access Sheaths During Retrograde Intrarenal Surgery on Postoperative Acute Renal Injury With IL-18 and L-FABP Biomarkers: A Prospective Randomised Study
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.
Read the detailed description
Urinary system stone disease is a common condition in urological practice, and with advances in minimally invasive surgical techniques, retrograde intrarenal surgery (RIRS) has become a widely preferred method, particularly for treating small and medium-sized kidney stones, owing to its high stone-free rates and low morbidity. The ureteral access sheath (UAS), routinely used during RIRS, offers advantages such as facilitating repeated entry and exit, shortening operation time, optimizing irrigation flow, and reducing intrarenal pressure. However, controlling intrarenal pressure is critical not only for surgical comfort but also for renal physiology and patient safety. Increased intrarenal pressure can lead to pyelovenous, pyelolymphatic, and pyelotubular regurgitation, increasing the risk of bacterial translocation, sepsis, and renal parenchymal damage. In particular, the damage that high intrarenal pressure can cause to the renal parenchyma and the resulting acute kidney injury (AKI) are of significant importance in critically ill patients who are clinically at risk of renal failure. Recent developments of aspiration-enabled intrarenal electroconvulsive (IOC) systems aim to more effectively and continuously control intrarenal pressure by providing active fluid drainage. Theoretical advantages of these systems include lower intrarenal pressure levels, improved visualization quality, and potentially lower complication rates. However, the effects of these systems on renal function have been evaluated in a limited number of studies in the current literature, and their effects, particularly on subclinical renal damage, have not been clearly established.
Acute renal injury (AKI) is a rare but clinically significant complication following RIRS, and it is often undetectable early using conventional biochemical parameters (e.g., serum creatinine). Therefore, the use of early and sensitive biomarkers is becoming increasingly important. In this context, Interleukin-18 and Liver-type fatty acid binding protein (L-FABP) stand out as promising biomarkers that can reflect early renal tubular damage and predict the development of AKI. The aim of this study is to comparatively evaluate the effects of aspiration and non-aspiration ureteral access sheath systems used during RIRS on postoperative acute renal injury, based on changes in IL-18 and L-FABP levels. Furthermore, by revealing the relationship between intrarenal pressure control and biochemical injury markers, the study aims to provide stronger evidence for the potential clinical benefits of aspiration systems.
- Conditions
- Urolithiasis
- Being tested
- flexible and navigable ureteral access sheath, conventional ureteral access sheath
- Keywords
- retrograde intrarenal surgery, acute kidney injury, IL-18, L-FABP
- Medical subject headings
- Urolithiasis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible and navigable ureteral access sheathDevice
Patients of RIRS operated with flexible and navigable ureteral access sheath
conventional ureteral access sheathDevice
Patients of RIRS operated with conventional ureteral access sheath
| Study group | Role | What they receive |
|---|---|---|
| Patients operated with FANS-UAS | Experimental | Not described Receives: Device: flexible and navigable ureteral access sheath |
| Patients operated with conventional-UAS | Active comparator | Not described Receives: Device: conventional ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
Serum IL-18 and L-FABP levels at the stated timelines.
Measured: preoperative, postoperative 24th hour and postoperative 7. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start4 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Fatih Şahin, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685587
- Sponsor's protocol ID
- 2026.170.05.32
- Acronym
- FANS
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 22982421Ecer 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.
PubMed 37133619
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Flexible and Navigable Suction With Conventional Ureteral Access Sheaths During Retrograde Intrarenal Surgery on Postoperative Acute Renal Injury With IL-18 and L-FABP Biomarkers: A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT07685587
- Acronym / sponsor ID
- FANS / 2026.170.05.32
- Conditions
- Urolithiasis
- Keywords
- retrograde intrarenal surgery, acute kidney injury, IL-18, L-FABP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Urinary system stone disease is a common condition in urological practice, and with advances in minimally invasive surgical techniques, retrograde intrarenal surgery (RIRS) has become a widely preferred method, particularly for treating small and medium-sized kidney stones, owing to its high stone-free rates and low morbidity. The ureteral access sheath (UAS), routinely used during RIRS, offers advantages such as facilitating repeated entry and exit, shortening operation time, optimizing irrigation flow, and reducing intrarenal pressure. However, controlling intrarenal pressure is critical not only for surgical comfort but also for renal physiology and patient safety. Increased intrarenal pressure can lead to pyelovenous, pyelolymphatic, and pyelotubular regurgitation, increasing the risk of bacterial translocation, sepsis, and renal parenchymal damage. In particular, the damage that high intrarenal pressure can cause to the renal parenchyma and the resulting acute kidney injury (AKI) are of significant importance in critically ill patients who are clinically at risk of renal failure. Recent developments of aspiration-enabled intrarenal electroconvulsive (IOC) systems aim to more effectively and continuously control intrarenal pressure by providing active fluid drainage. Theoretical advantages of these systems include lower intrarenal pressure levels, improved visualization quality, and potentially lower complication rates. However, the effects of these systems on renal function have been evaluated in a limited number of studies in the current literature, and their effects, particularly on subclinical renal damage, have not been clearly established.
Acute renal injury (AKI) is a rare but clinically significant complication following RIRS, and it is often undetectable early using conventional biochemical parameters (e.g., serum creatinine). Therefore, the use of early and sensitive biomarkers is becoming increasingly important. In this context, Interleukin-18 and Liver-type fatty acid binding protein (L-FABP) stand out as promising biomarkers that can reflect early renal tubular damage and predict the development of AKI. The aim of this study is to comparatively evaluate the effects of aspiration and non-aspiration ureteral access sheath systems used during RIRS on postoperative acute renal injury, based on changes in IL-18 and L-FABP levels. Furthermore, by revealing the relationship between intrarenal pressure control and biochemical injury markers, the study aims to provide stronger evidence for the potential clinical benefits of aspiration systems.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Having a planned RIRS operation
- Providing written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible and navigable ureteral access sheathPatients of RIRS operated with flexible and navigable ureteral access sheath | Device | Patients operated with FANS-UAS |
| conventional ureteral access sheathPatients of RIRS operated with conventional ureteral access sheath | Device | Patients operated with conventional-UAS |
Primary outcome
acute kidney injury
Time frame: preoperative, postoperative 24th hour and postoperative 7. days
Serum IL-18 and L-FABP levels at the stated timelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 22982421Traxer 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.
- Background: PubMed 37133619Ecer 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible and navigable ureteral access sheath and conventional ureteral access sheath in people with Urolithiasis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mehmet fatih M. şahin, associate professor (+90 555 551 1871, mfatihsahin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: preoperative, postoperative 24th hour and postoperative 7. days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685587, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.