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NCT Number: NCT07689565

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

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.

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Key information

Conditions

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

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Ureteral Access Sheath (Boston Scientific).

Device

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

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

Primary outcomes

  1. Stone-free rate (SFR)

    Time frame: 1 month postoperatively

    Absence of residual fragments or presence of clinically insignificant residual fragments measuring < 3 mm, assessed by postoperative CT scan.

Secondary outcomes

  1. Operative time

    Time frame: Intraoperatively . from insertion of sheath

  2. Intraoperative visibility and ease of access

    Time frame: intraoperatively

    Intraoperative visibility and ease of access using scale (good-moderate-poor)

  3. Intraoperative complications

    Time frame: intraoperatively

  4. Postoperative complications

    Time frame: up to 30 days postoperatively

    Postoperative complications (according to Clavien-Dindo classification).

  5. Need for auxiliary procedures.

    Time frame: up to 30 days postoperatively

    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

  6. Length of hospital stay.

    Time frame: From the day of surgery up to hospital discharge (estimated average of 3 days)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

khaled Mostafa elmaradney, MD

CONTACT

[email protected]

+201014508582

mohamed ebrahim elmaadawy, MD.PHD

CONTACT

[email protected]

+201060245430

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: FANS-UAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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