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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Ureteral Access Sheath (UAS) | Experimental | Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy. |
|
| FANS Ureteral Access Sheath (Elephant-II) | Experimental | Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard ureteral access sheath | Device | Participants undergo flexible ureterorenoscopy and laser lithotripsy using a standard ureteral access sheath according to institutional practice. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 months (+/- 1 month) post-procedure |
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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.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca LV Villa | Contact | 0226439742 | villa.luca@hsr.it | |
| Concetta Cangemi | Contact | 0226435662 | cangemi.concetta@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Flexible and Navigable Suction (FANS) Ureteral Access Sheath | Device | The Flexible and Navigable Suction (FANS) ureteral access sheath (Elephant-II), which enables active suction during flexible ureterorenoscopy and laser lithotripsy. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |