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OpenTrials
Completed

NCT Number: NCT05896345

Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.

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Key information

Conditions

Pediatric Kidney Disease

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1-2.5 cm renal stone
  • Normal Serum creatinine
  • Radiolucent stone with Hounsfield units less than 400

Exclusion criteria

  • Bleeding diatheses.
  • Patients with a pacemaker.
  • uncontrolled UTIs.
  • Severe skeletal malformations.
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.

Treatment and study plan

SWL

Device

Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone

SWL and ODT

Combination Product

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Primary outcomes

  1. Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm

    Time frame: 3 month

    percentage of patient who are stone free

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

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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