Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath

NCT07763743 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Not applicable

Started

2026-06-01

Last updated

2026-08-13

Condition(s) studied

Pediatric Renal Stones

Investigational drug(s) / intervention(s)

Flexible Ureteroscopy

Flexible Ureteroscopy: To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm

Study summary

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles.

Suction has emerged as a potentially transformative adjunct in both percutaneous nephrolithotomy (PCNL) and RIRS. Recent studies evaluating various suction mechanisms during RIRS and mini-PCNL have demonstrated multiple benefits, including reduced operative time, higher stone-free rates (SFR), decreased intrarenal pressure (IRP) and temperature, as well as enhanced intraoperative visualization.

Both FANS-UAS in RIRS and VAAS in Mini-PCNL have shown promising outcomes in the pediatric population. Taken together, these findings suggest that suction-assisted technologies whether in RIRS or Mini-PCNL enhance both efficacy and safety in pediatric stone management.

Eligibility

Sex

ALL

Min age

1 Year

Max age

14 Years

Healthy volunteers

Inclusion Criteria: \- Renal stone burden 1- 2.5 cm confirmed by imaging (CT or ultrasound). Exclusion Criteria: * Patients who refuse to participate in the study. * Untreated Urinary tract infection (UTI) proved by urine culture and sensitivity. * Uncorrected coagulopathy. * Anatomical anomalies or ureteral stricture precluding either surgical approach. * Previous surgical intervention on the same kidney.

Primary outcome measure(s)

Management of pediatric renal stones — 6 months
To compare stone-free rate (SFR) at 1 month after the procedure between RIRS using FURS-UAS and mini-PCNL using VASS in pediatric patients with renal stones 1-2.5 cm

Trial sites (1)

Facility	City	Region	Status
Ain Shams University Hospitals	Cairo	Abbasia	Recruiting

More Ain Shams University trials in Egypt

Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure Recruiting

3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM Active, not recruiting

Association Between Plasma D Dimer in Adult CAP and Severity of Inflammatory Response and Survival Recruiting

Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Plane Block for Postoperative Pain Control Following Video-assisted Thoracoscopic Surgeries (VATS): Randomized Control Trial Recruiting

Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763743 on ClinicalTrials.gov ↗ ← All trials in Egypt