Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm

NCT07689565 | Not Yet Recruiting

• 1 other identifier: 36265MS60 / 5 / 26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Stone; Nephrolithiasis; Pediatric Urolithiasis

Keywords

Flexible Ureterorenoscopy; Retrograde Intrarenal Surgery; Ureteral Access Sheath; Suction-Assisted Ureteroscopy; Pediatric Urology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Operative time

  Intraoperatively . from insertion of sheath

• Intraoperative visibility and ease of access

  intraoperatively

• Intraoperative complications

  intraoperatively

• Postoperative complications

  up to 30 days postoperatively

• Need for auxiliary procedures.

  up to 30 days postoperatively

Study Arms (2)

Group A: Standard UAS

ACTIVE COMPARATOR

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).

Group B: Suction UAS (FAAN)

EXPERIMENTAL

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).

Interventions

Standard Ureteral Access Sheath (Boston Scientific). DEVICE

Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)

Group A: Standard UAS

Flexible and Navigable Suction UAS (ClearPetra). DEVICE

Suction evacuation ureteral access sheath (Length: 30-35 cm, Size: 10/12 Fr or 11/13 Fr) with terminal flexible end

Group B: Suction UAS (FAAN)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Stones larger than 2 cm
• Active urinary tract infection
• Congenital urinary tract anomalies affecting access
• Previous ureteral surgery affecting the ureter
• Coagulopathy or unfit for surgery

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

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 Officials

• salah abdelmnsef nagla, MD-PHD

  Tanta unversity

  STUDY CHAIR

• osama mostafa elgamal, MD-PHD

  Tanta unversity

  STUDY DIRECTOR

• Mohamed ebrahim elmaadawy, MD-PHD

  Tanta unversity

  STUDY DIRECTOR

Central Study Contacts

khaled Mostafa elmaradney, MD

CONTACT

+201014508582; khaledelmaradney@gmail.com

mohamed ebrahim elmaadawy, MD.PHD

CONTACT

+201060245430; mohamed.elmaadawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology, Damanhour Teaching Hospital, Egypt

Model Details: Eligible pediatric patients will be randomly allocated into two equal parallel groups (1:1 ratio). Group A will undergo flexible ureterorenoscopy (FURS) using a standard ureteral access sheath (UAS), while Group B will undergo FURS using a flexible and navigable suction ureteral access sheath (FANS). Both groups will be followed up postoperatively to compare efficacy and safety outcomes.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 8, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)