FANS vs Standard Ureteral Access Sheath in fURS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard ureteral access sheath, Flexible and Navigable Suction (FANS) Ureteral Access Sheath.
- Who it may be relevant to
- Registry conditions: Renal Calculi. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Primary outcome measures
- Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan [Time frame: Within 3 months (+/- 1 month) post-procedure]
Eligibility criteria
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.
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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
- 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.
- Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT07463157 · CLEAR-URS