Flexible navigable suction ureteral access sheath versus traditional sheath for retrograde kidney stone removal
Official title: A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial
Run by Cairo University · NCT07076589 · Data updated 2026-11-12
This trial will test whether a flexible, navigable suction ureteral access sheath works better than a traditional sheath for people 14 and older having retrograde intrarenal surgery for kidney or ureteral stones up to 2 cm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | March 3, 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07076589 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 14 or older with a renal or ureteral stone ≤2 cm on CT, non-recurrent disease, non-infected urine, normal urinary anatomy, eGFR ≥60 ml/min, and no known stone-forming medical conditions.
✕Probably not a fit
Patients with abnormal urinary tract anatomy, active or uncontrolled urinary infection, eGFR <60 ml/min, metabolic stone-forming disorders, or prior open renal/PCNL on the same side are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares a flexible, navigable suction ureteral access sheath (FANS) with a traditional ureteral access sheath during retrograde intrarenal surgery (RIRS) for renal and ureteral stones ≤2 cm. Eligible patients are aged 14 and older with non-infected urine, normal renal anatomy, no prior open renal surgery or PCNL on the same side, and no known stone-forming medical conditions. Key outcomes include stone-free rate, clearance of residual fragments, intrarenal pressure–related complications including infection, and need for ancillary interventions. Procedures and follow-up are conducted at Cairo University Hospitals, with participants randomly assigned to FANS or traditional sheath arms.
Why it matters
Potential benefit: If successful, the FANS approach could increase stone-free rates, improve clearance of dust and fragments, reduce intrarenal pressure–related complications, and lower the need for additional procedures.
How similar studies have gone: Similar suction-based and pressure-control adjuncts for RIRS have shown promising results in early or small studies, but randomized head-to-head evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥14 years old in patients not known to have stone forming medical conditions. * Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching \& non-branching). * Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy. * Patients with non - infected urine analysis. Exclusion Criteria: * Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit). * Patients with medical conditions promoting stone formation (hyperparathyroidism - gout). * Patients with history of stones on the same side with previous open surgical intervention or PCNL . * Patients with e-GFR \< 60 ml / min. * Patients with uncontrolled urinary tract infection. * Patients with health or other factors that are absolute contraindications to RIRS. * Patients who are unable to understand or complete trial documentation.
Where it's running
-
Cairo university hospitals
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Ahmed Yehia Abdelaziz Mohammed, Professor of urology — Cairo University
- Study coordinator: Yosseif Ammar, MBBCH
- Email: yosefelhousseiny@gmail.com
- Phone: 201226912630
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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.