Skip to content

Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05413603
Enrollment
100
Registered
2022-06-10
Start date
2022-05-25
Completion date
2023-05-30
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only, Stone, Kidney

Keywords

pediatric renal stones, ultrasound shock waves, fluoroscope.

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

Interventions

PROCEDUREultrasonic focus Shock wave lithotripsy

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone

PROCEDUREfluoroscopic focus Shock wave lithotripsy

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Previous percutaneous nephrolithotripsy at the same side. 2. Previous renal exploration for stones at the same side. 3. Positive urinary culture. 4. Calyceal stones

Design outcomes

Primary

MeasureTime frameDescription
Lithotripsy or nephrolithotripsy by Shock wavesfrom 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

MeasureTime frameDescription
Complications of shockwave lithotripsythrough study completion, an average of 1 yearto evaluate postoperative complications of the lithotripsy as : 1. Incidence of Hematuria 2. Incidence of Fever 3. Incidence of UTI 4. Serum creatinine level in blood 5. Rate of hydronephrosis

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026