Flexible navigable suction ureteral access sheath versus traditional sheath for retrograde kidney stone removal

A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) Versus Traditional Access Sheath in RIRS : Randomized Controlled Trial

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT07076589 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Cairo

• Cairo university hospitals — Cairo, Egypt (Recruiting)

Study contacts

• Principal investigator: Ahmed Yehia Abdelaziz Mohammed, Professor of urology — Cairo University
• Study coordinator: Yosseif Ammar, MBBCH

Conditions Stones, Kidney; Ureter Stones