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Clinical Trials/NCT05413603
NCT05413603
Completed
Not Applicable

Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.

Egymedicalpedia1 site in 1 country100 target enrollmentMay 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stone, Kidney
Sponsor
Egymedicalpedia
Enrollment
100
Locations
1
Primary Endpoint
Lithotripsy or nephrolithotripsy by Shock waves
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Detailed Description

Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease. Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

Registry
clinicaltrials.gov
Start Date
May 25, 2022
End Date
May 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

Exclusion Criteria

  • Previous percutaneous nephrolithotripsy at the same side.
  • Previous renal exploration for stones at the same side.
  • Positive urinary culture.
  • Calyceal stones

Outcomes

Primary Outcomes

Lithotripsy or nephrolithotripsy by Shock waves

Time Frame: from baseline to 3 months after the Lithotripsy date.

Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.

Secondary Outcomes

  • Complications of shockwave lithotripsy(through study completion, an average of 1 year)

Study Sites (1)

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