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

NCT06729801 | Completed

• 1 other identifier: MERE2024-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

RIRS; FANS

Outcome Measures

Primary Outcomes (1)

• Operative Time

  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.

  Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).

Secondary Outcomes (2)

• Stone-Free Rate (SFR)

  24-48 hours post-surgery, based on CT scan results.

• Postoperative Complications

  Evaluated within 30 days post-surgery.

Study Arms (2)

IRP-Monitoring FANS Group

EXPERIMENTAL

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.

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

Conventional FANS Group

ACTIVE COMPARATOR

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.

Device: Conventional FANS

Interventions

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

IRP-Monitoring FANS Group

Conventional FANS 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.

Conventional FANS Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
• Willing to provide informed consent.
• No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
• Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.

You may not qualify if:

• Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
• Pregnancy or breastfeeding women.
• Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
• History of prior ureteral or renal surgery that may affect the anatomy.
• Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
• Patients who are unwilling or unable to comply with the study protocol.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Guohua Zeng

Guangzhou, Guangdong, 510230, China

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 7, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

CN (1)