NCT07463157

FANS vs Standard Ureteral Access Sheath in fURS

Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.

Detailed description

Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs \>1000 HU) and stone volume (\<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.

Conditions

• Renal Calculi

Interventions

Type	Name	Description
DEVICE	Standard ureteral access sheath	Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.
DEVICE	Flexible and Navigable Suction (FANS) Ureteral Access Sheath	The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.

Timeline

• Start date: 2026-03-15
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-03-11
• Last updated: 2026-03-12

Locations

1 site across 1 country: Italy