FANS vs Standard Ureteral Access Sheath in fURS
NCT07463157 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2026-03-12
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.
Conditions
- Renal Calculi
Interventions
- 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.
Sponsors & Collaborators
-
IRCCS San Raffaele
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-15
- Primary Completion
- 2029-01-31
- Completion
- 2029-01-31
Countries
- Italy
Study Locations
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