NCT06729801

Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery

Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.

Conditions

• Kidney Stone

Interventions

Type	Name	Description
DEVICE	IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)	The IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a novel device designed to enable real-time monitoring of intrarenal pressure (IRP) during retrograde intrarenal surgery (RIRS). It incorporates a pressure-sensing port connected to a gas conduit embedded in the sheath, which allows the surgeon to adjust irrigation flow and suction pressure based on real-time IRP readings, thereby optimizing stone retrieval efficiency while ensuring safety by maintaining a safe IRP range. The device improves surgical outcomes, particularly in complex cases involving larger renal stones, by reducing operative time and minimizing the risk of complications.
DEVICE	Conventional FANS	The Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) is a standard device used in retrograde intrarenal surgery (RIRS) for stone retrieval. Unlike the IRP-monitoring version, this device does not provide real-time monitoring of intrarenal pressure (IRP). Irrigation flow and suction pressure are pre-set and adjusted based on clinical protocols. It facilitates the removal of renal stones through a flexible and navigable design, but without the added capability of monitoring and adjusting IRP during the procedure.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2025-01-07
• First posted: 2024-12-11
• Last updated: 2025-01-17

Locations

1 site across 1 country: China