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

NCT ID: NCT06729801

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-07

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IRP-Monitoring FANS Group

Patients in this group will undergo retrograde intrarenal surgery (RIRS) using the intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS). This novel device provides real-time IRP monitoring, enabling the surgeon to adjust intraoperative irrigation and suction settings to optimize stone retrieval efficiency while maintaining IRP within a safe range.

Group Type: EXPERIMENTAL

IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)

Intervention Type: DEVICE

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.

Conventional FANS Group

Patients in this group will undergo RIRS using a conventional flexible and navigable suction ureteral access sheath (FANS) without intrarenal pressure (IRP) monitoring. The irrigation flow rate and suction pressure will be pre-set and adjusted based on standard clinical practices.

Group Type: ACTIVE_COMPARATOR

Conventional FANS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).

2. Willing to provide informed consent.

3. No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.

4. Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.

Exclusion Criteria

1. Patients with active urinary tract infections (UTIs) or fever at the time of surgery.

2. Pregnancy or breastfeeding women.

3. Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).

4. History of prior ureteral or renal surgery that may affect the anatomy.

5. Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.

6. Patients who are unwilling or unable to comply with the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guohua Zeng

Vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guohua Zeng

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

MERE2024-003

Identifier Type: -

Identifier Source: org_study_id