FANS vs Standard Ureteral Access Sheath in fURS (NCT07463157) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
FANS vs Standard Ureteral Access Sheath in fURS
Italy134 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant is willing and able to provide written informed consent before any study-specific procedures are performed.
✓. Male or female, aged 18 years or older.
✓. Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.
✓. In stable general health and fit for elective endoscopic surgery under general anesthesia.
✓. Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.
Exclusion criteria
✕. Solitary kidney (monorenal patients).
✕. Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
✕. Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
✕. Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required
✕. Concomitant ureteral stone
✕. Ureteral stenosis
What they're measuring
1
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
Timeframe: Within 3 months (+/- 1 month) post-procedure
. Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.
✕. Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.