NCT06889051

Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones

Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.

Conditions

• Nephrolithiasis
• Urolithiasis
• Endourology

Interventions

Type	Name	Description
PROCEDURE	Flexible & Navigable Suction Ureteral Access Sheath (FANS)	The Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).
PROCEDURE	Antegrade Suction via Percutaneous Nephrostomy	This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.

Timeline

• Start date: 2025-03-30
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2025-03-21
• Last updated: 2025-03-21