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NCT Number: NCT07506031

Shear Wave Elastography for Predicting Extracorporeal Shock Wave Lithotripsy Outcomes in Pediatric Renal Stones

This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.

Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.

This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of medicine Beni Suef university hospital

Banī Suwayf, 62511, Egypt

Location status: Recruiting

Location contact

doaa mahmoud kalil, MD

CONTACT

[email protected]

01152091011

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion criteria:
  • Single Renal stones measured 6- 20 mm in maximal dimension.
  • ESWL will be planned as the first line of treatment.

Exclusion criteria

  • Patients with internal ureteral stent.
  • ureteral stones.
  • abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
  • active UTI at time of ESWL.
  • coagulopathy .

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. ESWL Success Rate

    Time frame: 3 months with maximum 3 sessions ESWL

    Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection.

Secondary outcomes

  1. Secondary Outcomes Related to SWE and ESWL

    Time frame: Up to 3 months after ESWL

    Assessment of secondary outcomes including:

    • correlation between shear wave elastography (SWE) values and CT-derived Hounsfield units (HU).
    • Correlation between SWE and stone composition.

Study contacts

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

Mahmoud Abdallah Mahmoud, MD of urology

CONTACT

[email protected]

+2001155361979

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children "A Prospective Study"

Acronym: SWE-ESWL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 1, 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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