FANS vs Standard Ureteral Access Sheath in fURS (CLEAR-URS)

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Renal Calculi

Treatments: Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath; Device: Standard ureteral access sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT07463157

CLEAR-URS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant is willing and able to provide written informed consent before any study-specific procedures are performed.

2. Male or female, aged 18 years or older.

3. 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.

4. In stable general health and fit for elective endoscopic surgery under general anesthesia.

5. Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.

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Exclusion criteria

1. Solitary kidney (monorenal patients).
2. Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
3. Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
4. 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
5. Concomitant ureteral stone
6. Ureteral stenosis
7. Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.
8. 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.
9. Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Standard Ureteral Access Sheath (UAS)

Experimental group

Description:

Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy.

Treatment:

Device: Standard ureteral access sheath

FANS Ureteral Access Sheath (Elephant-II)

Experimental group

Description:

Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy.

Treatment:

Device: Flexible and Navigable Suction (FANS) Ureteral Access Sheath