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

Guangzhou Medical University

Status: Completed

Conditions: Kidney Stone

Treatments: Device: Conventional FANS; Device: IRP-Monitoring Flexible and Navigable Suction Ureteral Access Sheath (FANS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06729801

MERE2024-003

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

IRP-Monitoring FANS Group

Experimental group

Description:

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.

Treatment:

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

Conventional FANS Group

Active Comparator group

Description:

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.

Treatment:

Device: Conventional FANS