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NCT Number: NCT07780409

Flexible Ureteroscopy for Large Renal Stones in Children

This prospective single-arm interventional study evaluated the efficacy and safety of flexible ureteroscopy for the treatment of large renal stones measuring 2 cm or more in pediatric patients. All enrolled participants underwent flexible ureteroscopic stone disintegration using a single-use flexible ureteroscope and Holmium laser lithotripsy. The study was designed to assess whether this minimally invasive approach could provide effective stone clearance with acceptable perioperative safety in children with large renal stones.

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Key information

Conditions

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

Age range

0 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients diagnosed with renal stones.
  • Renal stone size ≥2 cm.
  • Age younger than 14 years.

Exclusion criteria

  • Uncontrolled urinary tract infection.
  • Impaired renal function.
  • Abnormal anatomical location of the kidney.
  • Congenital renal or ureteric anomalies.

Treatment and study plan

Flexible Ureteroscopic Stone Disintegration

Procedure

Flexible ureteroscopy was performed using a 7.5-Fr single-use flexible ureteroscope. Renal stones were fragmented with a Holmium:YAG laser. A ureteral access sheath was used when feasible, and a double-J ureteral stent was placed at the end of the procedure.

Primary outcomes

  1. Stone-Free Rate After Flexible Ureteroscopic Stone Disintegration

    Time frame: 1 month after the procedure

    Stone-free status was assessed by computed tomography of the urinary tract (CTUT) after flexible ureteroscopic stone disintegration. The proportion of participants meeting the study-defined criteria for stone-free status was recorded.

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperatively

    Duration of the flexible ureteroscopic procedure was recorded for each participant.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Flexible Ureteroscopic Stone Disintegration in Pediatric Age Group for Large Renal Stones (≥2 cm)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2026
Registry last updated
Aug 21, 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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