Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm (FANS-UAS)

Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm : A Randomized Controlled Study

This randomized controlled trial aims to compare the efficacy and safety of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus a standard ureteral access sheath during flexible ureterorenoscopy (FURS) in pediatric patients with renal stones less than 2 cm. The study will evaluate stone-free rates. operative time. intraoperative parameters. operative and postoperative complication and the need for any auxiliary procedures. Sixty pediatric patients will be randomly allocated into two equal groups and treated at the Urology Department, Tanta University.

Study Overview

• Status: Not yet recruiting
• Conditions: Nephrolithiasis; Kidney Stone; Pediatric Urolithiasis
• Intervention / Treatment: Device: Standard Ureteral Access Sheath (Boston Scientific).; Device: Flexible and Navigable Suction UAS (ClearPetra).

Detailed Description

Pediatric urolithiasis is an increasingly recognized condition associated with substantial morbidity and recurrence risk. Flexible ureterorenoscopy has become an established minimally invasive treatment option for renal stones smaller than 2 cm. The use of ureteral access sheaths facilitates repeated upper urinary tract access and may improve operative efficiency; however, concerns regarding ureteral trauma remain.

Recently developed suction-assisted ureteral access sheaths have been introduced to improve visibility, facilitate fragment evacuation, and reduce intrarenal pressure. Although promising results have been reported in adults, evidence in pediatric patients remains limited.

This prospective randomized controlled trial will compare a standard ureteral access sheath with a Flexible and Navigable Suction Ureteral Access Sheath (FANS) in pediatric patients undergoing flexible ureterorenoscopy for renal stones less than 2 cm.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: khaled mostafa elmaradney, MD; Phone Number: +201014508582; Email: khaledelmaradney@gmail.com
• Study Contact Backup: Name: mohamed ebrahim elmaadawy, MD.PHD; Phone Number: +201060245430; Email: mohamed.elmaadawy@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Tanta University
      • Contact: khaled mostafa elmaradney, MD; Phone Number: +201014508582; Email: khaledelmaradney@gmail.com
      • Contact: alaa abdelsamd alshazly, MD; Phone Number: +201068576598; Email: alaaabdelsamed0@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pediatric patients (age ≤ 18 years)
2. Patients with renal stones less than 2 cm
3. Indicated for flexible ureterorenoscopy
4. Fit for general anesthesia
5. Informed consent obtained from parents or guardians

Exclusion Criteria:

1. Stones larger than 2 cm
2. Active urinary tract infection
3. Congenital urinary tract anomalies affecting access
4. Previous ureteral surgery affecting the ureter
5. Coagulopathy or unfit for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Standard UAS; Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr) used during flexible ureteroscopic stone fragmentation using Holmium:YAG laser.	Device: Standard Ureteral Access Sheath (Boston Scientific).; Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)
Experimental: Group B: Suction UAS (FAAN); Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end enabling continuous drainage and suction during laser stone fragmentation	Device: Flexible and Navigable Suction UAS (ClearPetra).; Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free rate (SFR)	Absence of residual fragments or presence of clinically insignificant residual fragments measuring < 3 mm, assessed by postoperative CT scan.	1 month postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications		intraoperatively
Operative time		Intraoperatively . from insertion of sheath
Intraoperative visibility and ease of access	Intraoperative visibility and ease of access using scale (good-moderate-poor)	intraoperatively
Postoperative complications	Postoperative complications (according to Clavien-Dindo classification).	up to 30 days postoperatively
Need for auxiliary procedures.	This outcome measure will evaluate the requirement for additional interventions to achieve complete stone clearance or manage residual fragments. It will be assessed by recording the percentage of participants who require any secondary or ancillary surgical procedures (such as second-stage ureterorenoscopy, shock wave lithotripsy, or temporary stenting) within 30 days postoperatively	up to 30 days postoperatively
Length of hospital stay.	The duration of hospitalization will be calculated in days, from the date of the participant's admission/surgery until the actual date of discharge from the hospital	From the day of surgery up to hospital discharge (estimated average of 3 days)

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Chair: salah abdelmnsef nagla, MD-PHD, Tanta unversity; Study Director: osama mostafa elgamal, MD-PHD, Tanta unversity; Study Director: Mohamed ebrahim elmaadawy, MD-PHD, Tanta unversity

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric Urology; Retrograde Intrarenal Surgery; Ureteral Access Sheath; Flexible Ureterorenoscopy; Suction-Assisted Ureteroscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 36265MS60 / 5 / 26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No