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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

January 7, 2025

Conditions
Kidney Stone
Interventions
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.

Trial Locations (1)

510230

Guohua Zeng, Guangzhou

All Listed Sponsors
lead

The First Affiliated Hospital of Guangzhou Medical University

OTHER

NCT06729801 - Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery | Biotech Hunter | Biotech Hunter