Kidney StonesNCT07568990
Ureteral Access Sheaths in Endoscopic Kidney Stone Surgery
A study testing Non-aspirating ureteral access sheath and Aspirating ureteral access sheath in people with Kidney Stones, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Non-aspirating ureteral access sheath and Aspirating ureteral access sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 11 May 2027
- Phase
- Interventional
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, 19040
AHMET TAŞCI, +90 553 159 6690, ahmettasci400@gmail.com
AHMET TAŞCI
About this study
Official title: The Impact of Two Different Ureteral Access Sheaths on Success and Complications in Endoscopic Kidney Stone Surgery
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.
Read the detailed description
This study is designed as a prospective, randomized, comparative clinical trial to evaluate the effectiveness and safety of aspirating versus non-aspirating ureteral access sheaths in patients undergoing retrograde intrarenal surgery (RIRS) for kidney stones.
Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the collecting system, maintain low intrarenal pressure, and improve visualization. While conventional non-aspirating sheaths allow passive outflow of irrigation fluid, aspirating sheaths provide active suction, which may enhance fragment evacuation, reduce intrarenal pressure, and potentially decrease infectious complications. However, comparative clinical data between these two approaches remain limited.
In this study, a total of 70 patients aged 18 to 75 years with renal stones smaller than 2 cm will be enrolled after providing informed consent. Patients will be randomized into two groups using a computer-generated block randomization method. The first group will undergo RIRS using a non-aspirating ureteral access sheath, while the second group will undergo RIRS using an aspirating ureteral access sheath. All procedures will be performed using a standardized surgical technique.
Demographic characteristics, stone-related parameters, and perioperative variables will be recorded. Postoperative follow-up will include clinical and radiological evaluation. Stone-free status will be assessed during postoperative follow-up. Complications will be classified according to the Clavien-Dindo classification. Additional parameters, including operative time, fluoroscopy time, length of hospital stay, infection-related laboratory findings, and the need for auxiliary procedures, will also be evaluated.
The aim of this study is to determine whether the use of an aspirating ureteral access sheath improves surgical efficiency and safety compared with a conventional sheath. The results are expected to provide evidence to guide clinical decision-making in endoscopic kidney stone surgery.
- Conditions
- Kidney Stones
- Being tested
- Non-aspirating ureteral access sheath, Aspirating ureteral access sheath
- Keywords
- retrograd intrarenal surgery, kidney stone, kidney
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-aspirating ureteral access sheathDevice
A conventional ureteral access sheath that allows passive outflow of irrigation fluid during RIRS.
Aspirating ureteral access sheathDevice
A ureteral access sheath with an active suction system that facilitates removal of irrigation fluid and stone fragments during RIRS.
| Study group | Role | What they receive |
|---|---|---|
| Non-aspirating ureteral access sheath | Experimental | Patients undergoing retrograde intrarenal surgery (RIRS) using a non-aspirating ureteral access sheath. Receives: Device: Non-aspirating ureteral access sheath |
| Aspirating ureteral access sheath | Experimental | Patients undergoing retrograde intrarenal surgery (RIRS) using an aspirating ureteral access sheath. Receives: Device: Aspirating ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 weeks postoperatively
Secondary outcomes (4)
Operation time
Operative time is defined as the duration from the start of the operation to its completion.
Measured: Measured during surgery, from incision to closure (intraoperative period)
Length of hospital stay
Length of hospital stay is defined as the time from postoperative hospital admission to hospital discharge, measured in days.
Measured: From postoperative admission to hospital discharge, assessed up to 30 days
Intraoperative complications
Intraoperative complications are defined as any adverse events occurring during the surgical procedure, including but not limited to bleeding, ureteral injury, or technical difficulties.
Measured: From start to completion of surgery (intraoperative period)
Postoperative infectious complications
Postoperative infectious complications are defined as infection-related adverse events occurring after surgery, including fever, urinary tract infection, and sepsis.
Measured: From end of surgery to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start20 Apr 2026
- Primary completion11 Apr 2027 (estimated)
- Study completion11 May 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 Kidney StonesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Taşci, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568990
- Sponsor's protocol ID
- ETIK-2026-01
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and institutional data protection policies. All data collected in this study will be used solely for research purposes and will remain confidential.
Publications
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.
PubMed 39545972Gauhar 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.
PubMed 38789313