An observational study in Kidney Calculi and Nephrolithiasis, sponsored by Antalya Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Antalya Health Sciences University · Observational
The goal of this observational study is to compare conventional and suction (aspiration) ureteral access sheaths used during retrograde intrarenal surgery (RIRS) in adults with kidney stones.
The main questions it aims to answer are:
Researchers will compare patients treated with a conventional ureteral access sheath with patients treated with a suction ureteral access sheath during routine RIRS.
Participants will:
Retrograde intrarenal surgery (RIRS) is a widely used minimally invasive treatment for kidney stones. Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the kidney and to help maintain low intrarenal pressure. Suction (aspiration) ureteral access sheaths are a newer type of sheath that allows continuous removal of irrigation fluid and stone fragments during surgery, which may improve stone clearance and reduce infectious complications. This study aims to compare surgical outcomes, stone-free rates, and complication rates between conventional and suction ureteral access sheaths in patients undergoing RIRS. Both sheath types are CE-marked medical devices used within their intended purpose.
605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.
This study's planned enrollment of 160 is close to the median of 146 across 114 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Antalya Health Sciences University is the lead sponsor of 17 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with kidney stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) with either a conventional or a suction ureteral access sheath at the Department of Urology, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a conventional (non-suction) ureteral access sheath as part of routine clinical care.
Device: Conventional Ureteral Access Sheath
Adult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a suction (aspiration) ureteral access sheath as part of routine clinical care.
Device: Suction Ureteral Access Sheath
A standard CE-marked ureteral access sheath without suction, placed during RIRS to provide repeated access to the kidney and facilitate irrigation outflow.
A CE-marked ureteral access sheath connected to a negative-pressure suction system, placed during RIRS to allow continuous aspiration of irrigation fluid and stone fragments.
Stone-Free Rate
Proportion of patients who are stone-free, defined as no residual stone fragments or residual fragments smaller than 4 mm. Stone-free status will be assessed by non-contrast computed tomography (NCCT) or, for radiopaque stones, by plain kidney-ureter-bladder (KUB) radiography.
Time frame: 1 month after surgery
Postoperative Fever and Infectious Complications
Proportion of patients who develop postoperative fever (body temperature ≥38°C), urinary tract infection, or sepsis.
Time frame: Within 7 days after surgery
Operative Time
Total duration of surgery, measured in minutes from insertion of the ureteroscope to placement of the ureteral stent or end of the procedure
Time frame: During surgery
Postoperative Complications
Proportion of patients with postoperative complications, graded according to the Clavien-Dindo classification.
Time frame: Within 30 days after surgery
Total Laser Energy
Total laser energy delivered during lithotripsy, measured in kilojoules (kJ) as recorded by the laser device.
Time frame: During surgery
Length of Hospital Stay
Duration of hospital stay after surgery, measured in days.
Time frame: From surgery to discharge, an average of 1-3 days
Plan to share: No — Individual participant data will not be shared publicly due to patient confidentiality and because the informed consent form did not include permission for data sharing. De-identified data may be made available by the corresponding author upon reasonable request and with approval of the ethics committee.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Of 39 non-industry observational studies under Kidney Calculi, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 12 months is below that.
Counting every sponsor, half of 41 studies reached it within 42 months; a quarter within 12 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Antalya Health Sciences University