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Not yet recruiting NCT07689565

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

No phase Interventional Pediatric Urolithiasis Kidney Stone Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Ureteral Access Sheath (Boston Scientific)., Flexible and Navigable Suction UAS (ClearPetra)..
Who it may be relevant to
Registry conditions: Pediatric Urolithiasis, Kidney Stone, Nephrolithiasis. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Standard Ureteral Access Sheath (Boston Scientific).
    Standard UAS (Length: 28-35 cm, Size: 10/12 Fr or 9.5/11.5 Fr)
  • 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

Primary outcome measures

  • Stone-free rate (SFR) [Time frame: 1 month postoperatively]
Secondary outcome measures (6)
  • Operative time [Time frame: Intraoperatively . from insertion of sheath]
  • Intraoperative visibility and ease of access [Time frame: intraoperatively]
  • Intraoperative complications [Time frame: intraoperatively]
  • Postoperative complications [Time frame: up to 30 days postoperatively]
  • Need for auxiliary procedures. [Time frame: up to 30 days postoperatively]
  • Length of hospital stay. [Time frame: From the day of surgery up to hospital discharge (estimated average of 3 days)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07689565 · 36265MS60 / 5 / 26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗