FANS vs Standard Ureteral Access Sheath in fURS
Condition(s) studied
Investigational drug(s) / intervention(s)
Standard ureteral access sheath: Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan — Within 3 months (+/- 1 month) post-procedure
Proportion of participants classified as stone-free based on radiological evaluation using low-dose non-contrast computed tomography. Stone-free status is defined as absence of residual stone fragments \>=4 mm.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy |
More IRCCS San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07463157 on ClinicalTrials.gov ↗ ← All trials in Italy