Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
Primary Purpose
Stone, Kidney, Child, Only
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasonic focus Shock wave lithotripsy
fluoroscopic focus Shock wave lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Stone, Kidney focused on measuring pediatric renal stones, ultrasound shock waves, fluoroscope.
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
Sites / Locations
- Urology department - faculty of medicine, South Valley university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
fluoroscopic focus Shock wave lithotripsy
ultrasonic focus Shock wave lithotripsy
Arm Description
Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone
Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone
Outcomes
Primary Outcome Measures
Lithotripsy or nephrolithotripsy by Shock waves
Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.
Secondary Outcome Measures
Complications of shockwave lithotripsy
to evaluate postoperative complications of the lithotripsy as :
Incidence of Hematuria
Incidence of Fever
Incidence of UTI
Serum creatinine level in blood
Rate of hydronephrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05413603
Brief Title
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
Official Title
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stone, Kidney, Child, Only
Keywords
pediatric renal stones, ultrasound shock waves, fluoroscope.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluoroscopic focus Shock wave lithotripsy
Arm Type
Active Comparator
Arm Description
Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone
Arm Title
ultrasonic focus Shock wave lithotripsy
Arm Type
Active Comparator
Arm Description
Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone
Intervention Type
Procedure
Intervention Name(s)
ultrasonic focus Shock wave lithotripsy
Intervention Description
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone
Intervention Type
Procedure
Intervention Name(s)
fluoroscopic focus Shock wave lithotripsy
Intervention Description
successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone
Primary Outcome Measure Information:
Title
Lithotripsy or nephrolithotripsy by Shock waves
Description
Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.
Time Frame
from baseline to 3 months after the Lithotripsy date.
Secondary Outcome Measure Information:
Title
Complications of shockwave lithotripsy
Description
to evaluate postoperative complications of the lithotripsy as :
Incidence of Hematuria
Incidence of Fever
Incidence of UTI
Serum creatinine level in blood
Rate of hydronephrosis
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Moubarak, Resident
Organizational Affiliation
Urology department - faculty of medicine, South Valley university.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology department - faculty of medicine, South Valley university
City
Qinā
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
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