FANS vs Standard Ureteral Access Sheath in fURS
ConditionRenal Calculi
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Standard ureteral access sheath
DeviceParticipants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice.
Flexible and Navigable Suction (FANS) Ureteral Access Sheath
DeviceThe Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Standard Ureteral Access Sheath (UAS)Experimental treatment 1 intervention
Group B: FANS Ureteral Access Sheath (Elephant-II)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
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.
Time frame
Within 3 months (+/- 1 month) post-procedureSponsors and contacts
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Source ClinicalTrials.gov
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