Vacuum-assisted vs conventional ureteral access sheath in modern kidney stone surgery
Official title: The Comparison of the Efficacy and Safety of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Randomized Controlled Prospective Multicenter Study
Run by Namik Kemal University · NCT06684756 · Data updated 2026-11-12
This trial tests whether vacuum-assisted ureteral access sheaths improve stone removal and safety in retrograde intrarenal surgery for adults with kidney stones.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Namik Kemal University Academic / other |
| Locations | 1 site (Tekirdağ, Turkey) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2025 |
| Study ends | December 1, 2026 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06684756 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–85 undergoing RIRS with 11–13 Fr vacuum-assisted or conventional UAS.
✕Probably not a fit
Patients unlikely to benefit include those outside the age range or without an UAS used during RIRS, or with atypical anatomy impacting the procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two ureteral access sheath designs used during retrograde intrarenal surgery (RIRS) for upper urinary tract stones. It evaluates whether vacuum-assisted sheaths achieve higher stone-free rates and fewer complications than conventional non-vacuum sheaths. The study uses adults aged 18–85 undergoing RIRS with 11–13 Fr UAS, and assesses efficacy, safety, and intraoperative factors such as visualization and operative time. The trial builds on existing guidelines that support UAS use for better imaging and reduced intrarenal pressure, while exploring whether vacuum-assisted designs offer additional benefits. Primary outcomes include stone-free rate; secondary outcomes include complication rates and procedure-related metrics.
Why it matters
Potential benefit: If successful, patients could have higher chances of being stone-free after one procedure with fewer complications.
How similar studies have gone: Previous studies suggest vacuum-assisted UAS can improve visualization and fragment clearance, but direct comparisons in RIRS are limited and findings are not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Patients below 85 years of age * Patients with 11-13 FR conventional/vacuum-assisted ureteral access sheath (UAS) during retrograde intrarenal surgery Exclusion Criteria: * Patients with non-sterile preoperative urine culture * Patients with renal anatomic anomalies * Patients with a solitary (single) kidney * Patients with insufficient data * Patients under the age of 18, above the age of 85 * Patients without an UAS during RIRS * Patients without 11-13Fr UAS during RIRS
Where it's running
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Tekirdag Namık Kemal University
Tekirdağ, Turkey, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Mehmet F. Şahin, Ass. Professor
- Email: mfatihsahin@gmail.com
- Phone: +905555511871
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.