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

Not Applicable

Completed

• Conditions: Kidney Stone

• Registration Number: NCT06729801
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Study First Posted: 2024-12-11
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Study Completion: 2025-01-07
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative Time	Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).	The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS.

Secondary Outcome Measures

Name	Time	Method
Stone-Free Rate (SFR)	24-48 hours post-surgery, based on CT scan results.	The stone-free rate (SFR) will be measured postoperatively through non-contrast CT imaging. The SFR will assess the effectiveness of stone retrieval and the success of the procedure.
Postoperative Complications	Evaluated within 30 days post-surgery.	The rate of postoperative complications, including fever, infection, bleeding, or ureteral injury, will be recorded. This will help compare the safety profile of both FANS devices.

Trial Locations

Locations (1)

Guohua Zeng; 🇨🇳 Guangzhou, Guangdong, China